chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm at injection site - while this was expected for the first week or so after vaccination, the pain has persisted for the past 3 months. The dull ache at the injection site has recently begun to increase in intensity; it's not quite to the level of soreness immediately following the first shot, but it is building. Concerned, and now very hesitant about future boosters.
Patient received her 2nd dose of covid vaccine as Moderna  but her 1st dose was Pfizer. She has had no adverse reaction to either one.
2/4  day of shot  minor itcing at vac site  2/5  itching and sorness 2/6 very itchy and sore did not feel well and took ibuprofin. 2/7 and 2/8  1inch by 2 inch red itchy area.  then it improved for a couple days.  2/11  itching and soreness redness getting worse 2/12  large red very itchy hot area 4 inches by 5 inches
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt a little) and EYE INFECTION (developed an eye infection) 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 PAIN IN EXTREMITY (arm hurt a little) and EYE INFECTION (developed an eye infection). At the time of the report, PAIN IN EXTREMITY (arm hurt a little) and EYE INFECTION (developed an eye infection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. This case was linked to MOD-2021-071224.
11/05 @ 23:00: Onset of dizzyness, took antivert. 11/06 @ 08:00: Vertigo continued, slightly hoarse.
This spontaneous report was received from a nurse concerning multiple unspecified patients (demographics unknown). The patients' pertinent medical history and concurrent conditions were not provided. On unspecified dates, the patients were administered doses of improperly stored GARDASIL (Lot # K011562; expiration date: 08-APR-2017) (dose and route not provided). No adverse effect was reported. It was reported the following temperature excursion for the administered vaccines: high temperature: 49.1 F doe 1 hour 48 minutes and low temperature: 33.0 F for 35.9 hours. No previous temperature excursion was reported. This is one of several reports received from the same source. Additional information has been requested.
Approximately 40 - 45 minutes post vax pt complained of tickling feeling in mouth and coughing. Pt was treated with Benadryl and albuterol, and an improvement was noted.
Diarrhea and increased fussiness. No blood or mucus with stools. Also had intense crying for 2 days. No treatment needed.
Warm red circle over injection site. Roughly 1.5 in in diameter, and feels hard. Itchy as well.
Patient was given the vaccine then moved to seating area.  He then fainted.  Experienced fatigue, weakness, and low bp after fainting. Monitored bp for approximately 30 minutes. He had a normal bp then exited the pharmacy.
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Pfizer product on 02/01/2021 and 02/22/2021. They first tested positive for COVID-19 on 10/29/2021 via both PCR and antigen testing, at the nursing home at which they were a resident.  About 2 weeks later, they presented to emergency department on 11/12/2021; primary complaint was decreasing responsiveness and "profound" hypoxia. Two additional COVID-19 tests collected on 11/12/2021 were also positive. They were admitted to hospital on 11/12/2021 and died later on the same day.  The individual had a DNR order in place.
23JUN94 pt fussy & felt warm; mom noted tiny red macules on face, neck, back, chest & arms & legs; t99.8, listless, sl irritable & fussy; rash was same 25JUN & 26JUN AM seen by MD 26JUNAM noted erythematous mac pap lesion; dx viral exanthem
an expired Daptacel vaccine is given to a patient; Initial information received on 01-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA124198, 2019SA123826, 2019SA124197 and 2019SA124199 (same reporter).  This case involves five years old female patient who was vaccinated with an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Lot C5171AA, Expiry date: 23-Mar-2019) vaccine on 24-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE INACT (IPV) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  It was a case of actual medication error due to expired vaccine used.  It was not reported if the patient experienced any adverse event following vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. Since 08-AUG-2015, the patients were vaccinated with improperly stored PROQUAD (Merck) lot # L014401 expiration date 23-OCT-2016. No concurrent medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
she experienced a little headache; This is a spontaneous report was received from a non-contactable consumer (patient reported for herself) from a Pfizer-sponsored program.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot Number unknown, expiration date unknown), via an unspecified route of administration on 02Mar2021 as 2nd dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of vaccine on an unspecified date. On 02Mar2021, after receiving the 2nd dose of the Covid vaccine yesterday, she had experienced a little headache. Caller was wondering if Pfizer is doing a clinical trial about how long the antibodies stay in your system. The outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Tested positive for covid on December 19. Experienced 3 days of fever, congestion, cough.  Prescribed Paxlovid by doctor due to age and diabetes. Diagnosed as a "mild" case of covid. No fever for last eight days.  Some congestion remains.
Patient in for well child visit, pt was incorrectly administered adult dose of Hep B vaccine- Engerix B.  Provider was made aware, Manufacturer contacted by nursing supervisor,  provider contacted parent, parent made aware of vaccine administration error and possible side effects and to contact office for any issues.
Undiluted Pfizer COVID 19 vaccination for patients age 5-11 was administered. 0.2ml of undiluted vaccine was administered to the patient. Patient was monitored for over 15 minutes with no adverse reaction. Followed up with the patient 6 hours later and patient was still without any adverse reaction. Manufacturer was contacted and sent guidelines stating that dose did not need to be re-administered and may receive 2nd dose 21 days after.
04may90 pt vax hepta B. pt devel excessive fatigue. 04jun90 pt vax 2nd hepta b. 15jun90 pt devel excessive fatigue and chest pain in sternal region radiating up to rt side of neck. sx resolved.md advised pt not to take further vax.
Patient got both doses of moderna March/April. In AUgust had a syncope episode w/ back pain. Presented to hospital with Malignant pleural effusion and recurrence of lung cancer. Bilateral leg DVTs, refractory to treatment and needing thrombosis X2; has a PE; Minor brain infarcts, and non bacterial endocarditis
Information has been received from a 68 year old male consumer referring to himself. There was no concurrent condition or medical history reported. The patient stated that, in June 2013, he got an initial PNEUMOVAX 23 and more recently on 02-DEC-2015 the patient got another dose of PNEUMOVAX 23 25/0.5 (unit unknown) (0.5 ml, lot # unknown) intramuscularly at a pharmacy. There was no concomitant medication reported. The patient stated that within 12 hours after receiving PNEUMOVAX 23 on 02-DEC-2015, he noticed a very obvious pink line about a quarter inch wide running down from the injection site area to his bicep. The patient also felt sore in the muscle and today, on 04-DEC-2015, there was still a mild amount of tenderness around the injection site. The patient mentioned he went back to the pharmacy today to let them know about his adverse reaction. Treatment with TYLENOL was given. The patient got general yearly blood work. At the time of the report, the outcome of pink line from the injection site area to bicep and sore in the muscle was unknown, and the outcome of tenderness around the injection site was not recovered. Additional information has been requested.
Increased heart rate; Chills; Muscle pain; Nausea; Headache; fever of 100.5; This is a spontaneous report received from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) (at the age of 27-years-old) via an unspecified route in the left arm on 23Mar2021, at 12:15 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as no. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine and did not received any other medications within 2 weeks of vaccination. The patient did not have allergies to medications, food or other products. On 23Mar2021 at 13:15, the patient had a fever of 100.5 (unspecified units) within 1 hour of shot lasted for about 8 hours followed by chills and muscle pain, increased heart rate, nausea and headache. The patient did not receive any treatment for the reported events. Adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of fever of 100.5, chills and muscle pain, increased heart rate, nausea and headache was resolving at the time of report.  Information on lot/batch number has been requested. No further information is expected.
This spontaneous report was received from a Registered Nurse (R.N) concerning a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL lot # K010215 (dose, and route not reported) which was improperly stored. Concomitant medications were not provided. It was reported that the vaccine was exposed to 34.3F for 360 hours and there was no previous temperature excursion. No adverse symptoms were reported. Additional information has been requested.
disoriented, stomach pain, diarrhea, high fever(patient didn't state), unable to stand, and chills.
Patient is a 12 year old female arrived to observation area complaining of nausea, weakness, noted to be diaphoretic.  Instructed patient to remain calm, relax.   arrived to scene for further evaluation.  Vital signs rendered EKG rendered.  Pt. denies any pain, discomfort.  Pt. refused hospitalization.   Pt. recovered from adverse event and left via personal vehicle with mother at 4:10pm.
GUM INFECTION; This spontaneous case (PVX2019-1329) report was received from a caregiver on 24-May-2019. It describes a female consumer who had gum infection, after the administration of Vivotif for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif on 13-May-2019, on the same day she developed gum infection. She competed the Vivotif course and waiting to start clindamycin capsule (150 mg; three times a day), which was prescribed to her as a treatment medication. The gum infection was still present, but it was not as bad as before.   She had an oral surgery for wisdom teeth removal about three to four weeks ago from which she got gum infection.  The consumer did not take any concomitant medication.   Action taken with Vivotif was dosage maintained.  The consumer had been recovering from the event.  The reporter considered the event gum infection unrelated to vaccine.  Company's Comment: In this case, the patient developed gum infection after the administration of Vivotif. Since gum infection is an infectious condition the causality of the event was assessed as unlikely with Vivotif.; Sender's Comments: Company's Comment: In this case, the patient developed gum infection after the administration of Vivotif. Since gum infection is an infectious condition the causality of the event was assessed as unlikely with Vivotif.
Patient came in on 9/15/17 arm where injection was given was slightly warm and swollen. He said it hurt and then right before it felt like a belt was on it. He had movement and said it felt a little better. He went to Urgent Care.
C/o pain going down left arm and shoulder to elbow & neck forearm at times. Unable to move arm due to pain after receiving flu shot. Went back to the doctor and pain meds given, but not relief after a week still having symptoms.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 11-JUL-2018, the patient was inadvertently vaccinated with expired PNEUMOVAX 23 lot # M042599 with expiration date 17-JUN-2018, intramuscularly, for prophylaxis (dose was not reported). No adverse effects were reported.
Information has been received from a Licensed Vocational Nurse referring to an unspecified number of patients of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On unknown dates the patients were vaccinated with improperly stored doses of GARDASIL for prophylaxis (strength, dose, dose number, lot #, route and application site were not reported. Concomitant therapy was not reported. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
1/2 hour after vaccine administered developed tingling in cheeks and metallic taste on lips.  No local rash, redness or tenderness.
7 cm x 5 cm area of mild erythema on right arm. 1 cm x 1 cm area of firmness at site of immunization.
Within 24 hours pt started to experience migraine headaches, extreme fatigue, after 72 hours, pt started experiencing microseizures, at 96 hours, pt sought medical attention to r/o other neurological causes - after CT head, was determined symptoms were the result of reaction to vaccine
It was just like a minor cold with cough. Over the next 3 days I just isolated from everyone and just wore a mask around people. On December 2, I was given a rapid/24-hour COVID-19 test which was positive and then I was given Paxlovid. I was on the Paxlovid and was really tired that lasted for almost 4 weeks. I do believe I had a rebound COVID case because I felt like I improved after a day or to and things got bad all over again.
Patient developed a nodule with redness and warmth at injection site about 5 minutes after receiving their second dose of COVID-19 vaccine. The reaction subsided after patient received a dose of oral diphenhydramine. and released from the vaccine clinic without requiring any further intervention.
This spontaneous report as received from a health worker refers to unspecified patients of unknown age. On an unknown date the patients were vaccinated with PROQUAD (dose and lot# not reported). It was reported that the temperature excursion of -13C up to 808 hours to VARIVAX which was supported. Multiple individuals had been vaccinated post excursion. And no individuals had been vaccinated post excursion. And no individual had reported any adverse effects post vaccination. This is one of the several reports from the same reporter. Additional information has been requested.
inadvertently administered the 2 doses of the vaccine to a 17 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inadvertently administered the 2 doses of the vaccine to a 17 year old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036b21a and 013a21a) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inadvertently administered the 2 doses of the vaccine to a 17 year old). On 22-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inadvertently administered the 2 doses of the vaccine to a 17 year old) had resolved.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment medications were not provided by the reporter. Action taken with mRNA-1273 in response to the events were not Applicable. The patient received both the doses with no adverse event.   This case was linked to MOD-2021-225150 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up received on 16-Jun-2021 describes about second dose , race information and ethnic group.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number 013A21A) with no associated AEs reported.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 03-JUL-2015, the patient was vaccinated with an improperly stored dose of M-M-R II lot # K016154 with exp. 24-SEP-2016, (route and dose were not provided). No adverse effect reported. This one of several reports received from the same reporter. Additional information has been requested.
Patient felt lightheaded after vaccine on 11/14. We gave ice pack and a water bottle and had him sit for a bit. He ultimately decided to leave and go home.   On 11/15 patient called to report to me he has progressively felt more sick. He vomited late last night 11/14 and again this morning 11/15. Now just nausea. Also experiencing muscle aches and pains.
Received the 1st dose of the Moderna vaccine on 17Apr2021 and for his 2nd dose of vaccine, he was administered the Pfizer Vaccine yesterday 20May2021; Vertigo; Had throwing up; Was very tired; Has severe pain in the left arm; Fever; This is a spontaneous report from a contactable consumer (patient).   A 57-years-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EW0177) via an administered in left arm via unknown route of administration on 19May2021 at 11:15 am as dose 2, single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE, Batch/Lot Number: 048BZ1A) via an unknown route of administration on 17Apr2021 at 12:45 to 17Apr2021 12:45, at dose 1, single for an unknown indication. Medical history included ongoing diabetes mellitus diagnosed 4 years ago. The patient's concomitant medications were not reported.  The patient received first dose of the moderna vaccine on 17apr2021 and for his second dose of vaccine, he was administered the pfizer vaccine yesterday 20may2021. On 20May2021, the patient having like vertigo, had throwing up and has severe pain in the left arm where he took the doses of the vaccines and fever. The patient reported the events began just now and he was very tired and slept and when he woke up he was standing up a little bit and throwing up and had severe pain in his left arm where he took the doses of the Moderna and Pfizer vaccines. It was reported that the events are ongoing but better after he threw up. The outcome of all the events was reported as unknown.  Information on lot/batch number was available. Additional information has been requested.
Leg of injection "size of 4 softbays" per mom. Per ER-cellulitis- Rx: KEFLEX. Much better within 36 hrs.
Day of the vaccine developed soreness, swelling and redness at vaccine site. Overall aches and pains. Lasted 4 days, with fever on day two. On day two developed a "spongy" or paresthetic sensation of bottom of the feet that is still present 7 weeks later.
2nd day, swelling, pain area shot admin 3rd day more swelling, pain and pain under arm, 4th day same called Dr, Advil used.
Hives began on underside of upper arms and thighs, spread sporadically on body and is still intermittently persisting, especially at night.
Patient received the 2nd COVID dose 20 days after their first COVID dose.  The patient's first dose was on 1/11/2022 and their second dose was on 1/31/2022.
Headache, chills for 2 days.  Treated with Tylenol which helped to alleviate symptoms.
Information has been received from a doctor of pharmacy concerning a female patient, who on approximately 02-FEB-2011, "one week ago", was vaccinated with a possible first dose of PNEUMOVAX 23  (it was unknown if the patient had also received this dose) and on 09-FEB-2011 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 667692/1110Z). The pharmacist reported that on 09-FEB-2011 the patient developed swelling and pain at the injection site. At the time of report, the patient's outcome was unknown. This is one of several reports received from the same source. No further information is available.
Mom said that her daughter started vomiting on Saturday after getting the shot on Tuesday. She also had dry heaves.
Information has been received from a physician concerning a 16 year old female who was vaccinated with two doses of Gardasil (lot#'s not reported) and developed hives on her legs after both doses.  Subsequently, the patient recovered from hives on an unspecified date.  Therapy was discontinued.  The patient sought unspecified medical attention.  The patient's first dose was given at another office.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/14/2008. Information has been received from a physician concerning an 18 year old female who was vaccinated intramuscularly in the left deltoid on 07-NOV-2007 with her second dose of GARDASIL the patient experienced bruising/swelling on the anterior aspect of the left Tibia, bumps on her face, neck and scalp/and a rash on her right forearm and hand. Subsequently the patient recovered from bruising/swelling on the anterior aspect of the left deltoid, bumps on her face, neck and scalp and a rash on her right forearm and hand. The patient experienced Erythema Nodosum at the time of vaccination. Additional information has been requested.