chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A 28 year-old female developed an injection site reaction with arm numbness after receiving two doses of RabAvert. The patient's past medical history included post-traumatic stress disorder. Concomitant medications included Valium and Ambien on an as needed basis.  The patient was bitten by a wild raccoon on 29 Oct 02. She received a tetanus shot on 30 Oct 02. Two doses of RabAvert were subsequently administered on 05 Nov 02 and 08 Nov 02. After receiving both RabAvert doses the patient complained of stinging and burning at the injection site immediately and at 2 hours after each injection. She also complained of a heaving feeling in the arms and numbness for one week, stating that her arms felt like they were asleep. The first dose of RabAvert was given in her left arm (the patient is left-handed), which the second dose was given in her right arm. With each dose she experienced these injection site reactions. By the time the patient received here second dose of RabAvert, her left arm was still hurting. The patient considered these events unacceptable, stating that she could not pick up her children because her arm hurt so much. She subsequently failed to return for the remaining doses.   The events resolved approximately one week after each RabAvert injection.
Pt reported thickness is throat and tingling in tongue. Vital signs remained stable for 30 minutes. BP 129/59, HR 72, RR 20, 94-97% O2 on room air. 25mg PO Benedryl administered. Pt tolerated and reported feeling better prior to leaving clinic. Patient advised to go to ED or Employee Health if any other symptoms occur.
Patient received her vaccination on 914. Patient started developing her symptoms that evening including significant abdominal bloating along with diarrhea. Patient had persistent diarrhea the following day along with nausea and vomiting. When walking back from a bowel movement from the restroom the patient had a syncopal episode and was caught by her husband. She had a loss of consciousness for about 30 seconds. She resumed consciousness without complication she had no seizure like activity. She was able to return to her bed. She was evaluated. A basic metal panel was performed she had no evidence of dehydration and had normal renal function. We provided normal saline infusion and Zofran for nausea.  Pt had and xray performed for her ankle as she twisted it when she collapsed. She was noted to have a distal tibia fracture. Patient is tolerating food and fluids at this time but still has persistent diarrhea and generalized weakness. She is will be evaluated and treated by orthopedics for her ankle fracture.
fatigue since vaccine to current, GI bleed req hospitalization 1 day hemaglobin drop 4 points in 1 day and colonscopy, iron transfusion  x5 wks for iron def macrocytosis anemia. hematoma. x 2  opening of incision. headaches and migraines since May. anxiety worsening req meds, vonwillebrands
Lighter periods after first two doses.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2021 (Lot number: EJ1686) as dose 1, single and administered in arm left, administration date 28Jan2021 (Lot number: EL3302) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hyperlipidaemia" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; WELLBUTRIN. Past drug history included: No, reaction(s): "Allergy". The following information was reported: HYPOMENORRHOEA (non-serious) with onset 2021, outcome "unknown", described as "Lighter periods after first two doses.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Facility where the most recent COVID-19 vaccine was administered doctor's office/urgent care. The patient was not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications patient received within 2 weeks was birth Control. Prior to vaccination the patient was not diagnosed with COVID-19. Previously always regular periods on schedule. Two pregnancy tests taken and both negative. Since the vaccination the patient had not tested for COVID-19. Device date was 10Dec2021.  No follow-up attempts are possible. No further information is expected.
Joint swelling in Fingers and in ankles; Tingling Sensation; Fever - Temperature of 100.4F; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of JOINT SWELLING (Joint swelling in Fingers and in ankles), PARAESTHESIA (Tingling Sensation) and PYREXIA (Fever - Temperature of 100.4F) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced JOINT SWELLING (Joint swelling in Fingers and in ankles), PARAESTHESIA (Tingling Sensation) and PYREXIA (Fever - Temperature of 100.4F). The patient was treated with NAPROXEN SODIUM (ALEVE) for Symptomatic treatment, at an unspecified dose and frequency. On 04-Feb-2021, JOINT SWELLING (Joint swelling in Fingers and in ankles), PARAESTHESIA (Tingling Sensation) and PYREXIA (Fever - Temperature of 100.4F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature: 100.4 (High) fever 100.4F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was Not applicable.  Concomitant medication also included Anti-inflammatory to alleviate symptoms.; Reporter'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.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for 4 adolescent patients. This is the 2nd of 4 reports. An adolescent patient of an unspecified ethnicity and gender received TRUMENBA (Lot# F26962), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced headache, redness, pain radiating down arm to hand, fever of 103 and swelling all on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 103. Sender's Comments: Linked Report(s): US-PFIZER INC-2017256820 Same reporter/drug/event, different patient.
elbow swelled up,entire arm feels like its being sliced with razor blade, knees fingers tingling, cant drive
pain in the middle of back initially then lower back then it went to upper back; its more like lower back burning sensation and dull pain in the middle back.; have swollen armpit for several days; pain under my shoulder blades; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW017), via an unspecified route of administration on 01May2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: ER8729), via an unspecified route of administration on 08Apr2021 as dose 1, single for covid-19 immunisation. Patient stated, I have back pain kind of moves around each day it started like dull pain in the middle of back initially then lower back then it went to upper back, under my shoulder blades, upper back. Today, it's more like lower back burning sensation and dull pain in the middle back. So, every day it is little different. Sometimes, it is better but sometimes is back pretty badly. This is now medicated as well and started going away a bit, but I have swollen armpit for several days and first over the period of 6 days it started going away and now it is almost back to normal not quite but almost. Patient stated, I took Tylenol 3 days not in a row I do not take it every day I took it twice in morning last week, like morning and evening. I took Tylenol Saturday morning and then today I took it once. So, it's 2 pills each time. Patient asked to help sort of how to medicate the side effect experiences 10 days post of second dose of a vaccine. Therapeutic measures were taken as a result of the events with Tylenol. The outcome of the events was reported as recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
NO ADVERSE EVENT; This spontaneous case was reported by a consumer and describes the occurrence of NO ADVERSE EVENT (NO ADVERSE EVENT) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Sinus infection.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NO ADVERSE EVENT (NO ADVERSE EVENT). At the time of the report, NO ADVERSE EVENT (NO ADVERSE EVENT) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient was prescribed antibiotics for a sinus infection that started BEFORE the shot. Has not started taking it. Fluticasone (has been taking off an on), The dentist prescribed Augmentin and she wants to start it today 875mg 2/day for 10 days.    Most recent FOLLOW-UP information incorporated above includes: On 08-Mar-2021: Additional (contact information updated)
Patient was actually being seen in our hospital as an outpatient for Procrit injection and lab work.  The Top care nurse felt the patient should be seen in the ER so she directed him to sign in as an ER patient.  Patient had a mass on the right deltoid that started on 5/8 after receiving the second Moderna vacation on 5/6.  The swelling peaked a few days later and now it has been getting better for the last week.  No fevers, no nausea or feeling ill.  Patient stated he would not have signed in to the ER if not for being asked to do so by the top care nurse.  He receives weekly Procrit and lab work.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
p/vax pt was itching @ site of inj;lt arm sore where vax given;noticed lt upper lip swollen & felt itchy all over;rash;papular erythemic spot;swollen;
PAIN FROM FIBROMYALGIA IS GONE; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included liver disease, and liver surgery, and concurrent conditions included fibromyalgia, immunocompromised, and high blood pressure, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included magnesium sulfate for cramping due to liver disease, oxycodone hydrochloride for fibromyalgia, spironolactone for high blood pressure, and prednisone for liver pain, and cramp.  On 09-APR-2021, the subject experienced pain from fibromyalgia is gone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain from fibromyalgia is gone was not reported. This report was non-serious.
Fever, chills, shortness of breath, chest pains, hoarse, body aches.
This spontaneous case, initially received on 06-Dec-2016, was reported by a health professional and concerns an adult patient of unknown age and gender. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): On an unknown date, the patient received AFLURIA (pre-filled syringe). Dose regimen: Not reported, Route of administration: Not Reported. Batch number: WT52005 or WT56607. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date within one week of being dosed, the patient experienced fatigue (outcome: not reported), flu like symptoms (outcome: not reported), heart palpitations (outcome: not reported), nausea (outcome: not reported), vomiting (outcome: not reported).
Presented with chest pain and dyspnea. Admitted to the hospital. Initially, the diagnosis was NSTEMI. Further testing showed myocarditis.
i was vacinated at the 15th of january in the evening! Everything was perfect and i was happy, just my legs itched, but on Sunday I suddenly noticed the beginning of an allergie which i normally get just in summer if I swim in standing waters with reef inside.  I got a rash on my neck and my tongue felt bit swollen and as my eyes. In the evening i took a cortisone tablet and ointment and it was much better. The ointment i still take, but no tablets anymore. I still do have rash but it is much better. now I am concerned about the second vacine, can you give me a recommendation?
Allergic reaction to the Varivax # 2 vaccine that was given on 9-21-21.  I have red, feverish, and welp around where the injection was given on my right upper arm on back side. After the shot was given on 9-21-21 & I had taken a Tylenol to help with the feverish & redness. The area has gotten a little bigger and I was told by RN that I needed to have this looked at by The ER physician. I was seen Hospital ER on 9-23-21 & was given IV Benadryl & antibiotic through IV along with the ER had drawn some lab work.
pt recv vax 14SEP95 & 20AUG97 pt devel chickenpox;
arm became very itchy; arm became very itchy, swollen (size of a baseball)/is still swollen; Hot to touch; arm became very itchy, swollen (size of a baseball), red; Pain; Redness; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PRURITUS (arm became very itchy), VACCINATION SITE SWELLING (arm became very itchy, swollen (size of a baseball)/is still swollen), SKIN WARM (Hot to touch), VACCINATION SITE ERYTHEMA (arm became very itchy, swollen (size of a baseball), red) and VACCINATION SITE PAIN (Pain) in a patient of an unknown age and gender 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 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain) and VACCINATION SITE ERYTHEMA (Redness). On 15-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (arm became very itchy), VACCINATION SITE SWELLING (arm became very itchy, swollen (size of a baseball)/is still swollen), SKIN WARM (Hot to touch) and VACCINATION SITE ERYTHEMA (arm became very itchy, swollen (size of a baseball), red). At the time of the report, VACCINATION SITE PRURITUS (arm became very itchy) and VACCINATION SITE SWELLING (arm became very itchy, swollen (size of a baseball)/is still swollen) had not resolved, SKIN WARM (Hot to touch) and VACCINATION SITE ERYTHEMA (arm became very itchy, swollen (size of a baseball), red) was resolving and VACCINATION SITE PAIN (Pain) and VACCINATION SITE ERYTHEMA (Redness) had 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.   Treatment and concomitant medications were not provided by reporter.; 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.
I had a sore arm for about a day after receiving the vaccine. On 04/22/2023 I started not feeling well with a runny nose and a cough. I went to the emergency room on 04/24/2023 as I was having trouble breathing and I had a fever that I could not break. I tested positive for COVID-19 on 04/26/2023. I contacted my provider and I prescription for Paxlovid. I tolerated the medication without any difficulties. As of today, I have a cough and my ears are itchy. I continue to take medication for allergies to help control my symptoms. I'm also very tired.
This spontaneous report as received from an unspecified nurse via a Company Representative refers to a pediatric patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On an unknown date the patient was vaccinated with a dose of GARDASIL, intramuscular (lot number was not provided). It was unspecified if the patient had received more than one dose in the series or if this was the first administration in the series. The reporting nurse mentioned that the patient had been diagnosed with encephalitis, shortly after the patient was vaccinated with GARDASIL. The patient was reported to be hospitalized at an unspecified facility, at the time of this report (approximately in February 2014). The outcome of encephalitis was unknown. No reporter causality was provided. Encephalitis was considered medically significant upon internal review. Additional information has been requested.
Pt. came back to pharmacy the day after immunization given. Pt. c/o difficulty sleeping, chest pain, upper back pain, SOB, increased heart rate - pt. stated these occurred overnight and currently some abdominal pain and lower back pain. RPh recommended she contact OB/GYN or if gets any worse go to ER.
Day 2 (12/29/20): Fever (<100 degrees), Mild muscle aches, Fatigue Day 3 (12/30/20): Fatigue, Muscle aches Day 4 (12/31/20): Alternating chills and profuse sweating starting at 8am, Full body flushing, Grand Mal Seizure at 4:30pm
Awoke with horizonal diplopia on post-vaccine day #2 after 2nd COVID vaccine. Had mild arm pain, diffuse myalgias on post-vaccine day #1, but resolved on post-vaccine day #2. No headaches or other fever, chills. No other focal neurologic issues. No prior history of eye issues. Diplopia completely resolved on post-vaccine day #3.
Moderate injection site pain; Mild redness around injection site; Mild swelling around injection site; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the right arm on 12May2021 at 16:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD) and major depressive disorder (MDD). The patient had known allergies to lactose. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), lamotrigine (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) and buspirone hydrochloride (BUSPIRON); all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12May2021 at 22:00, the patient experienced moderate injection site pain, mild redness around injection site and mild swelling around injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events moderate injection site pain, mild redness around injection site and mild swelling around injection site was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Redness, swelling size of tennis ball from elbow to shoulder, itching, pain - severe sharp pains at site. Iced site for 2 days. Took ADVIL & BENADRYL & sleeping pills at night. Shoulder numb & weak.
They have 7 or 8 people positive for covid at this time; all of them have received the vaccine and 6 people out of 7 or 8 that are infected have the Pfizer BioNTech Covid19 vaccine; They have 7 or 8 people positive for covid at this time; all of them have received the vaccine and 6 people out of 7 or 8 that are infected have the Pfizer BioNTech Covid19 vaccine; This is a spontaneous report from a Contactable Nurse. This nurse reported similar events for 5 patients. This report is 2nd of 5 reports. A 62-year-old patient of an unspecified gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8734) via an unspecified route of administration as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, patient tested positive for COVID. Reporter was calling to report an outbreak of covid in the long term care setting where she works at. It was reported that they have 7 or 8 people positive for covid at this time; all of them have received the vaccine and 6 people out of 7 or 8 that are infected have the Pfizer BioNTech Covid19 vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the event was unknown.; Sender's Comments: Based on the known safety profile of the drug, a causal association between the reported events of drug ineffective and covid-19 and suspect drug bnt162b2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202101058200 same product and event, different patients
Patient fainted 15 min after injection. During the time of unconsciousness patient urinated. When she regain conscious she then began gagging.
After receiving flu vaccine, pt. had a black & blue painful area on her arm that was present for 2 months. It did go away for a few weeks but is now back & has been for about 2-3 weeks. She states that it is very painful, & she doesn't know what else could be causing it.