chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Slight temporary dizziness right away, which could have been from blood pressure Mild headache within 15 mins - gone the next day Metal taste right away for two days and then intermittent for a couple of days Mild sore arm an hour or so after that lasted for about 4 days Moderate fatigue after about 3 hours - gone the next day Mild joint pain about 5 hours after - gone the next day
Gave vaccine at about 5:40pm. Patient soon after felt faint, hot and overall not well. Upon observation, she was also shaking and appeared distressed.  She was not sure what was happening and probably thought it was anxiety. She didn't have any reactions prior. I talked to her to get her to calm down a little, offered her a lollipop (to increase her sugar intake) and had her sit. She felt better after 15 minutes and she left after verbally confirming she was feeling better.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M041080 with expiration date 06-OCT-2018 and lot # M037642 with expiration date 01-SEP-2018 (dose and route of administration were not reported), which were reconstituted with sterile diluent (STERILE DILUENT). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of -2.4C degrees Celsius for 1 hour 14 minutes. A Digital Data Logger was involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA014902: US-009507513-1705USA007303: US-009507513-1705USA007304: US-009507513-1705USA007305: US-009507513-1705USA007306: US-009507513-1705USA007307:
Pt received vaccination Friday afternoon. Developed 103 degree fever Saturday evening & continues all day Sunday. Fever went down to 102 degrees on Monday and then broke. Patient also vomited early Sunday morning.
Information has been received from the grandmother of a female pt who was vaccinated with a dose of varicella virus vaccine live. Subsequently, she developed hives and 2 weeks later developed chickenpox. Unspecified medical attention was sought. It was noted that the patient recovered. There was no product quality complaint involved. Additional information has been requested.
Achy, exhausted and cold sweats.  Began about 12 hours after shot and still feel the same
Parent reported big red arm and fever on 05/15/06 in am. Late in afternoon (430pm) of same day, I observed redness, warmth, swelling of left arm of pt from shoulder to elbow.
Tender and warm back of right arm 6 x 8 cm almost at axillary area.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 19-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), 0.3 ml single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE : 3 (1st BOOSTER), UNKNOWN MANUFACTURER.), for COVID-19 immunization; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer.), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Temperature is 103.7"; CHEST PAIN (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "pain in both arms and in his chest"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "lymph nodes on the side of the vaccine are swollen". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: He had feels much sicker after this than before. He had pain in both arms and in his chest. His lymph nodes on the side of the vaccine are swollen of course. Temperature is 103.7 which was not usual. Stated he had nothing relevant, he doesn't have medical conditions and doesn't take medications. Just had usual reactions to prior vaccines. Caller stated these side effects are a lot more serious than in the past noting that he only had a slight fever and sore arm. Caller stated she was aware of the chance of heart involvement with the vaccine.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
A cluster of six unidentified adults received intramuscular injections of DAPTACEL (lot number C2605AA).  All six patients experienced redness and swelling at the injection site and fevers ranging from 99 - 100 degrees Fahrenheit.  All six patients recovered.  No additional details were provided.
bilat submandibular lymph node 4cm x 3cm;pt still has enlarged lymph nodes p/a month;
got shingles / was vaccinated about 2 years ago with Shingrix/Suspected Vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, more than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: This case was reported via Interactive Digital Media. The age at vaccination was not reported. The reporter stated that needed treatments to supplement vaccines. The patient received dose of shingrix about 2 years prior to the report and just got shingles. This case was considered as suspected vaccination failure as details regarding laboratory confirmation were unknown at the time of reporting. The information regarding consent to follow up was not reported.
I received my first Covid Vaccine dose last Friday April 2nd. Just soreness from the shot and feeling tired. Saturday morning I felt nauseous as well but drank water and was fine. On Thursday4/8 early morning around 2am, I woke up in a panic. My heart was racing and I was very dizzy and could not sit still. It lasted for two hours but improved after drinking tons of water. Yesterday,  4/8, while I was working, around 4pm I finished eating in the cafeteria and as I'm walking to the elevator, I lost focus and felt as if I was going to pass out. My heart began to race as it did that early morning and I could not stand still. I was able to make it on the elevator and when I got to my nurses station I began to lose focus again. I alerted my charge nurse, she escorted me to the waiting area and sat me down and began to check my vitals. My temperature was 98, blood pressure was 139/88 and sugar was fine as well since I just ate. I sat for the next hour drinking water and I eventually was able to get up and I was fine.
This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 30-AUG-2016, the patient was vaccinated with improperly stored dose of VAQTA lot number reported as: LN749, expiry date: 26-AUG-2018 (strength, dose number, route and anatomical location were not provided). Concomitant therapies were not provided. This is one of the several reports received from the same reporter. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of rash acneiform in a 46-year-old male patient who received BOOSTRIX (batch number 594SR, expiry date 8th July 2019). Co-suspect products included FLUARIX QUADRIVALENT (batch number 9M3F7, expiry date 30th May 2018). Concomitant products included ARIMIDEX. On 23rd August 2017, the patient received BOOSTRIX (intramuscular) .5 ml and FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, less than a month after receiving BOOSTRIX and FLUARIX QUADRIVALENT, the patient experienced rash acneiform and incorrect storage of drug. On an unknown date, the outcome of the rash acneiform was not recovered/not resolved and the outcome of the incorrect storage of drug was unknown. The reporter considered the rash acneiform to be unrelated to BOOSTRIX and FLUARIX QUADRIVALENT. Additional details were reported as follows: At the time of reporting, the patient returned to the pharmacy and reported an acne-like rash from his hips down on both sides of legs. In August 2017, the BOOSTRIX given to the patient was part of lot that was left outside of the refrigerator for 4 hours, which led to an incorrect storage of vaccine. The healthcare professional contacted GlaxoSmithKline Medical Information at that time to confirm whether the vaccine was acceptable to use. The healthcare professional was not concerned about the temperature excursion and felt it had nothing to do with patient's adverse event.
Pt woke up the next day after receiving her 2nd dose of Moderna. States had movable lymph nodes in clavical area that were not painful.  Went to see PMD at clinic in city on 05-25-2021 who started Cephalexin 500mg PO BID x 10 days. Pt also states that right eye developed slight swelling on 05/25/2021.
The 9 patients received expired vaccine in November and in December.; 2nd dose administered  beyond dosing interval window period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The 9 patients received expired vaccine in November and in December.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered  beyond dosing interval window period) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The 9 patients received expired vaccine in November and in December.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered  beyond dosing interval window period). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The 9 patients received expired vaccine in November and in December.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered  beyond dosing interval window period) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The 9 patients received expired vaccine in November and in December.  Expired vaccine was administered with no adverse event reported. Allergy to medication, food and other products was unknown. There was no acute illnesses at the time of vaccination and up to one month before. The patient had never been diagnosed with/ tested positive for COVID-19. Chronic or long-standing health conditions were unknown. Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination and/or at the time of adverse event were unknown. The event did not cause the patient to seek medical advice. No other potential cause were reported. The patient did not experience similar event in the past. No treatment medication information was provided.
Treatment of COVID-19; Treatment of COVID-19; Dose Number 4: Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 at 09:30 as dose 5 (booster), single (Lot number: GH9694) at the age of 65 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Mar2021 at 11:00 as dose 1, single (Lot number: EN6201), in left arm, on 24Mar2021 at 11:00 as dose 2, single (Lot number: ER8732), in left arm and on 05Nov2021 at 14:00 as dose 3 (booster), single (Lot number: FF2593), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Apr2022 as dose 4 (booster), single (Lot number: 005M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: latex(mild)" (unspecified if ongoing); "AV block w/pacemaker" (unspecified if ongoing); "MGUS" (unspecified if ongoing); "environmental allergies mild" (unspecified if ongoing); "AV block w/pacemaker" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE, start date: 01May2022; B-COMPLEX [VITAMIN B NOS], start date: 01Dec2021; OSTEO NUTRIENTS II (WITH VITAMIN K2-7), start date: 01Dec2022; FEXOFENADINE HYDROCHLORIDE, start date: 01Dec2020; MAGNESIUM CITRATE, start date: 01Oct2020. Past drug history included: Wellbutrin, reaction(s): "known allergies: Wellbutrin".  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 13Apr2022, outcome "unknown", described as "Dose Number 4: Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Positive, notes: On Day #10 woke with sore throat, cough, and hoarseness, runny nose and had positive antigen test.  (COVID rebound); (Jan2023) Negative, notes: Tested negative day 6 and 9; (Jan2023) Negative, notes: Tested negative day 6 and 9. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received Anti-viral Product Brand Paxlovid for COVID 19 Treatment started on 09Jan2023 and stopped on date 13Jan2023. The patient experienced Metallic mouth, intermittent nausea while taking Paxlovid side effects stopped on day #6 after finishing Paxlovid. All COVID symptoms ceased. Tested negative day 6 and 9. On Day 10 woke with sore throat, cough, and hoarseness, runny nose and had positive antigen test. (COVID rebound).
Patient received shot on 10/9/2020. Patient started to feel unwell the following day. By 10/13/2020 her arm felt really hot. Patient stated that even clothes touching her arm caused burning pain. Patient went to Doctor 10/14/2020 and was diagnosed with bacterial cellulitis. Doctor prescribed Cephalexin 500 qid for 10 days which patient took. Prescribed Prednisone 20 mg qd which patient did not take.
The patient was administered a volume of 0.25mL instead of the appropriate volume of 0.5mL. The error was recognized the following day and outreach was made to Moderna and CDC for clinical recommendations for the next step. Upon response from the clinical team 9 days later the patient was informed of the error and was given the direction to return to the pharmacy at as soon as possible to receive a complete dose of 0.5mL. No adverse events had been reported. Patient has not yet returned for full dose
This spontaneous report as received from a registered pharmacist refers to a 46 year old female patient with no drug reactions or allergies. On an unknown date "years ago", the patient was vaccinated with a dose of MMR II (dose, route and lot # not reported). The pharmacist reported that in December 2014 "within the last two weeks", the patient underwent a blood titer was negative for mumps antibodies. The patient's present status was unchanged since that blood titer was performed. The patient did not receive treatment for the adverse event. Additional information has been requested.
Feeling sick, AFIB occurrences, had a fever on 2nd day of 100.8, left shoulder hurt from shot and just felt very bad all over!
Patient received one dose of Pfizer in another country on 4/18/2021 and then received Dose 2 of Moderna (Spike-VAX) in another country on 6/19/2021. Patient was given Moderna booster. Patient did not have any reactions reported.
diffuse erythematous rash-macular patches, chest pain; rx DPH & Ibuprofen
This spontaneous report as received from a nurse refers to a 35 year old patient (gender unknown). Pertinent medical history, drug reactions or allergies were not reported. On 28-JUL-2014, the patient was vaccinated with VARIVAX, 0.5 ml, subcutaneous (lot # was not reported). On 05-AUG-2014, the patient was inadvertently administered another dose of VARIVAX, (dose, route and lot # were not reported). No adverse effects reported. Additional information is not expected because the reporter refused further follow up.
Soreness/ Tenderness around injection site. Muscle soreness 3" side to side of site. Muscle soreness 5" above & below site.  First occurrence Day of. Continued thru 24hrs AFTER injection
I got a lamp  under my left armpit after 1st dose and with 2nd dose it got bigger and it?s hurtful.
Got really sick, weak, had to get 3 course of antibiotic after receiving FLUZONE High Dose [v. high fever, v. dizzy, coughing].
This is in follow-up to reports(s) previously submitted on 4/6/2007. Initial and follow-up information has been received from a registered nurse concerning a 22 year old female with allergies to tetracycline, VICODIN and TRAMADOL who on 12-JAN-2007 at 1:45 PM, was vaccinated IM into the left arm with a 0.5 mL first dose of GARDASIL (Lot# 653650/0697F). There was no illness at the time of vaccination. Concomitant therapy included medroxyprogesterone acetate (DEPO-PROVERA) and ALLEGRA. On 13-JAN-2007 the patient called complaining of a fever that started on the day of the injection at 8:00PM. The fever was about 102 degrees. Subsequently, the patient recovered and there were no other problems reported. Additional information is not expected.
This non-serious spontaneous case, initially received from other non-health professional (consumer) on 19-Feb-2018, concerning a female patient of unspecified age. The patient's medical history and concomitant medication was not reported. On an unspecified date, the patient was administered FLUCELVAX QIV (dose, route of administration, anatomical location, batch number and expiry date: not reported). On an unspecified date, the patient experienced itching and swelling on the left side of the face after administration of the vaccine. At the time of this report, the outcome of the events (itching and swelling on the left side of the face) was not reported. This case was considered as lost to follow-up.
Mild headache, dizziness, tiredness, feeling of vomiting, but next day it got worse with high fever 103.3 F, loss of appetite, on Thu I couldn't go to work, chills, body ache, really bad headaches, feeling weak, the area was red and swollen.
Patient received a half-dose booster rather than a full dose though he reported being immunocompromised
GBS strongly suspected  Patient received dose #2 of Moderna COVID vaccine on 02/12/21. She had a low grade fever and lower extremity aches that evening. The morning of 02/13 she began experiencing tingling in her bilateral toes. She presented to the emergency department 02/17 because this lack of sensation continued to progress until she had no sensation to her mid thigh and began to be unable to feel her perianal region. Her fingertips also started to go numb. She also reported some diplopia.  Received IVIG  Somewhat improved strength and sensation on discharge. Discharged to inpatient rehabilitation facility
chills have been caller's response from the start, from the initial COVID vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient received bnt162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills have been caller's response from the start, from the initial COVID vaccine". Additional information: Patient confirmed that it was a Pfizer COVID vaccine.
Non blanching hyperpigmented macular rash to abdomen and chest, coalescing and pruritic, smaller lesions up to 1 cm size to upper arms and thighs. Preceded by chills and aches.
I can feel my heart beat stop every once in awhile, through out the day, for a few days now
Information has been received from a physician concerning a 65 year old male with no significant medical history who on 08-AUG-2009 was vaccinated with a dose of PNEUMOVAX (lot no. not reported) into the left arm. On 09-AUG-2009 the experienced weakness and pain in the injection arm. The patient also had fever of 1002F which continued for 6 days. Physician reported that the area was not cellulitic and there was no obvious source of fever. The physician stated that patient had brachial plexus and the patient was not able to move his arm at all. At the time of the report the patient had not recovered. The patient sought medical attention at the doctor's office. Follow up information has been received from the physician, concerning 69 year old (previously reported as 65 years old) retired male patient with no illness at the time of vaccination and no known allergies, who on 08-AUG-2009 at 8:30 am, was vaccinated with the first dose of PNEUMOVAX, intramuscularly in the left deltoid. 48 hours after injection, the patient complained of severe pain, weakness of left shoulder and left arm, with no erythema. In the medical examination the patient had marked tenderness on left deltoid and severe weakness of left shoulder abduction, left elbow flexion and extension; left hand grip, left wrist extension and flexion. There was no sensory deficit. The physician diagnosed the patient with left brachial plexitis. On an unspecified date, the patient recovered with full strength after the physician injected 80 mg DEPO MEDROL into the left subdeltoid bursa. The physician considered left brachial plexitis to be disabling and other important medical event. No further information is expected.
pt recv vax & exp soreness & pain @ inj site lasting 1wk;MD was required;tx unk;sx have resolved;
Within weeks of the inoculations I developed shortness of breath and fatigue which became increasingly severe. I thought it was because of aging. During late summer the symptoms became more sever to the point that I had difficulty ambulating. During the night of October 20, 2022 I was unable to breathe and my wife called 911. I was taken by ambulance to the Medical Center. I was told I was suffering from a pulmonary embolus and underwent immediate cardiac catheterization. Multiple clots were removed some of which were judged to be months old. I spent a few days in the hospital and was discharge to follow up care. Have been taking Eliquis, Metoprolol, and Losartan ever  since.