chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 25-SEPT-2013 the patient was vaccinated with M-M-R II (lot # J002502, expiration date 28-FEB-2015). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for 15 minutes, 17-SEP-2013 for 35 minutes, on 19-SEP-2013 for 1 hour and 35 minutes, on 20-SEP-2013 for 40 minutes and on 25-SEP-2013 for 45 minutes. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008372, 131USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008405, 1310USA008406, and 1310USA008407 (same reporter linked). Additional information has been requested.
04/24/21 FIRST DOSE , SHE NOTICED A SM NODULE A THE SITE OF VACCINE ON L UPPER ARM... on 4/25/21 IT WAS A SIZE OF A SM GOLF BALL, IT IS RED, WARM AND ITCHY. 04/26- The size has grown to nearly a tennis ball and its puffy. She has taken Advil -  200 MG ( 2 tabs ) and Benadryl cream.
Grandmother reported client is sleepy, had loose stools on 11/22/2021 and "his bottom is bright red."  He c/o of sore arms- grandmother did not notice redness or swelling. Poor appetite last night and this morning.
Backache, Runny Nose, Sensitivity to Light,  Vertigo which lasted 2 Weeks
Lacy rash was present on abdomen prior to HIB/Hep B vaccine. Rash worsened over night. Blisters on face. Looks like Erythema Infectiosum.
body ache/ all over achy feeling; muscle aches; feeling like coming down with the flu; This is a spontaneous report from a contactable healthcare professional (patient). A 58-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EJ1685), via an unspecified route of administration on left arm at 11:45 AM on 22Dec2020 at single dose for COVID-19 immunization. Medical history included Graves Disease and COVID-19 (Prior to vaccination, diagnosed with COVID-19). Concomitant medication included ibuprofen (MOTRIN), diclofenac sodium. The patient previously took percocet and experienced allergies, darvocet and experienced allergies. The patient experienced body ache and muscle aches the day after first shot also feeling like coming down with the flu all over achy feeling on unknown date that resolved in a days time. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovered on unknown date.
Large area of swelling at injection site, warm to touch. Red, covering shoulder and extending down halfway to elbow. Seen in office 1/17/02--Benadry 1 tsp every 6 hours. Seen in office 1/19/02--still swelling, redness and complains of left leg pain not bearing weight. 1/21 swelling down, no longer limp on left leg.
Vaccinated 12/17 and got bumps 12/26. Thought nothing of it but slowly got a few more. 1/1 got fever and bump on arm. Wondering if this is related to MMR vaccine.
Pt is 33 1/7 pregnant , due date is 03/08/2023. Pt was administered Tdap today when in chart realized pt was already administered Tdap on 01/03/2023, provider and preceptor was notified.
It was so like burning; Had a lot of pain; Hot flashes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 14:00 (Lot number: ER8730) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: VIT C; VIT D. The following information was reported: PAIN (non-serious) with onset 25Mar2021, outcome "recovering", described as "Had a lot of pain"; HOT FLUSH (non-serious) with onset 25Mar2021, outcome "recovering", described as "Hot flashes"; BURNING SENSATION (non-serious), outcome "unknown", described as "It was so like burning".  Additional information: On 25Mar2021, The patient experienced had a lot of pain, hot flashes. On an unspecified date, it was so like burning. The patient stated that she had her 1st vaccine on 5Apr2021 and had a lot of pain and hot flashes like crazy pain in her body and hot flashes like crazy and she handled that, it was a lot of pain and a lot of hot flashes, it was crazy, not usual for her. Stated it was so like burning, she did not have a fever, nothing else and she doesn't know what is going on at all and she was disappointed and angry and at work worrying about her health because she got the vaccine. The reporter also said from the minute she put it on for the 1st dose, about an hour or so she started to have a lot of pain and a lot of hot flashes. Stated they got better but didn't go away and provides that the card says 1st dose 25Mar2021 at Soka University, and she got it at 2pm in her left arm. The outcome of pain, hot flush was resolving and burning sensation was unknown.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a nurse practitioner vial a company representative refers to an unspecified number of patients of unknown ages and genders. On unknown dates the patients were vaccinated with ZOSTAVAX, 0.65 ml one dose, subcutaneous (SQ) (lot# and expiration date not reported). On unknown dates the unspecified patients had developed redness and swelling at the injection site after receiving a ZOSTAVAX vaccination. The patients sought medical attention and reported to the office. The action taken with therapy was unknown. The outcome of the events was unknown. Additional information has been requested.
Cough, shortness of breath, fatigue, body aches, headache, runny nose, congestion Today 1-30-2021 headache is finally gone, lingering cough, congestion is better, some aches in my shoulders
Rash or hives covering abdomen, chest and inner arms. Started around waistline and spread from there. I took Benedryl, Zyrtec and did Colloidal Oatmeal baths. Rash inflammed 4/4, 4/5, 4/6 and beginning to be less so on 4/8, 4/9 but bumps still present.
Lower back cramping night off vaccine. Back continued hurting for 12 days so went to Orthopedic doctor.
Tingling, itchy throat, clamminess, nausea. BP 124/75, pulse 81, O2 sat 100%. Given water and stabilized.
In addition to extreme soreness at the injection site, I experienced sleeplessness, fever, chills, muscle and body aches. I also fainted.
Reports T1DM following vaccine receipt. Pt with normal H & P on 16 May 2007. Experienced symptoms of polydipsia, fatigue, and polyuria with sudden onset of visual changes in early July 2007. Also had about 15 lb. weight loss over 3 week period prior to diagnosis. Sought evaluation and was diagnosed with DM. Initial glucose was 358 and pt was started on Amaryl and Metformin. Insulin initiated in March 2008, but continues on Metformin. Ht 6 ft 9 in; wt 174 pounds (at time of dx).  9/26/08 Reviewed medical summary of 8/22/2008. FINAL DX:Type 1 diabetes Records reveal patient experienced initial series of anthrax vaccines 2000-2004; then had booster 5/16/2007.  Symptoms of hyperglycemia began approx 6/2007 w/polydipsia, polyuria, fatigue, weight loss, blurred vision, irritability.  Tx w/oral agents beginning 7/07 & increased to max by 3/08; started on insulin.
Fever, muscle pain, pain at the injection side, burning sensention from head to fingers at the injection side.
2JUN97 pt recv vax 1PM-slept 30min then started crying inconsolable for 5-6 hr;mom called MD same day said to watch child carefully;mom gave APAP;
Moderna COVID-19 Vaccine EUA - Severe swelling the size of a softball under right arm. Severe pain in right arm. Unable to lift arm very high. Low grade fever, sweats, headache, fatigue. Swelling is getting worse and it is the 3rd day since vaccine.
Rash occurred after vaccination.  Patient did not seek medical attention.  No treatment was provided.  Even reported by family 2 days after vaccine administered.
AKI, hypotensive, and hypokalemia with COVID-19 infection requiring hospitalization
localized reaction of erythema, swelling, tenderness and fever with max temp of 103
Administered expired vaccine to patient/ Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient/ Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient/ Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient/ Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that 168 doses were administered with Lot number 048C21A. The vial did not undergo any temperature excursions. Date the vial initially stored in the refrigerator was unknown.  Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: The follow-up document includes non-significant information.
Pt began to have tinnitus about a week after receiving the vaccine. This has been and is expected to be permanent. Pt has seen audiology to get a hearing aid to help mitigate.
adm to hosp 9NOV93-cardiogenic shock; severe idiopathic & cardiomyopathy currently w/acute resp failure, renal failure;
I woke up with a headache at 7:30 am and a dry mouth. I got out of bed to get my water bottle, which exacerbated the headache. I tried to go back to sleep but kept waking up to drink water every half hour or so, until 10:18 am. I got out of bed to fill my now-empty waterbottle. The headache rotated and became more intense as I got up. I could only walk very slowly and tried to keep my eyes closed. Around 12:00 pm I took one tylenol. The headache is still present. It is not located in any specific part of the brain but moves around depending on if I'm sitting, standing, or laying down. During that time I also felt nauseous, but I no longer do.
5/09/03-5/15/03 continuous acute pain Rt side of jaw & neck radiating to behind the ear.  No temp.  But waking up in the night drenching with sweat "I just feel bad".  Lymph node size of quarter swollen Rt side of neck.  Started Keflex 500mg TID today.
Localized edema, mild pruritus at left lateral arm (area of injection). No erythema, extremity with FROM, no tenderness to manipulation. No contusions or parathesia. CNS intact.  Follow up on 06/05/2000: "Patient recovered from adverse event. Patient recieved further shots since reported event."
Patient says that the pharmacist poked a bone in arm and requires physical therapy. She is been complaining of arm pain ever since.
4 days p/ vax pt devel rash of about 20 pox located on her extremities & behind the ears, exp headache, nausea, mild fever of 100 degrees.
Swelling salivary glands, fever 101- 3days, h/a, aching joints;
I developed oral thrush. I?ve never had any oral problems before, not even a cavity. The doctor said that he had seen it in a few patients who have had Covid before. Whether that?s from the vaccine or actual Covid, I?m not sure. I did test positive for Covid a week after getting my shot in May.
Multiple spots with erythema, multiple vesicles more than 20 face/chest/head.
I had a migraine the day after and was fatigued but no way to know if the vaccine triggered that.  My arm was sore for about 3 days.  It has been itching since the day after but on day 7, I developed a light pink rash.  It had darkened on day 8.  It is red and hot to the touch and itches badly.  I still have the rash, heat and itching at this time.  I have taken Benadryl to help with the itching and do not yet know if it has helped. (I just took it before filling this out)
Numbness & Tingling left corner of my lips/mouth,  started 40 minutes after vaccine , lasting 3 hours. Bilateral numbness  to skin on knees noted in the middle of night while sleeping & resolved upon waking today @ 6:00am.
15 hours after vaccine-awoke with headache, confusion (slight), temp 100.4 degrees, thirst, chest discomfort. Took Tylenol and tepid shower. Felt better one hour later. Totally recovered by later in AM.
Deep Vein Thrombosis; Chronic Fatigue for months; Diplopia; Aneurysm in Ascending Aorta; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 66-year-old male patient received bnt162b2 (BNT162B2), on 13Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "BPH" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: Not Available, Location of injection: Arm Left), administration date: 23Jan2021, when the patient was 66-year-old, for COVID-19 immunization. The following information was reported: AORTIC ANEURYSM (disability, life threatening) with onset 20Sep2021 at 12:45, outcome "recovered with sequelae", described as "Aneurysm in Ascending Aorta"; FATIGUE (disability, life threatening) with onset 20Sep2021 at 12:45, outcome "recovered with sequelae", described as "Chronic Fatigue for months"; DEEP VEIN THROMBOSIS (disability, medically significant, life threatening) with onset 20Sep2021 at 12:45, outcome "recovered with sequelae"; DIPLOPIA (disability, life threatening) with onset 20Sep2021 at 12:45, outcome "recovered with sequelae". The events "deep vein thrombosis", "chronic fatigue for months", "diplopia" and "aneurysm in ascending aorta" required physician office visit. Therapeutic measures were taken as a result of deep vein thrombosis, fatigue, diplopia, aortic aneurysm. Treatment received included referral to Ultrasound/PCP, Put on Eliquis. Covid test type on 23Dec2021 (Nasal Swab) on 23Dec2021: negative.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, an association between the reported events AORTIC ANEURYSM, FATIGUE,DEEP VEIN THROMBOSIS, DIPLOPIA  and The suspected drug cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300296256 Same patient, same events, different dose;
Around 7:00pm on 6/28, the day after my second dose of Moderna, I noticed my arm was splotchy around my injection site and that it felt swollen. A few hours later I looked at it again in better light and noticed it was hive. They are raised and flat in large patches, covering about 15 sq. in. of my bicep. I haven't treated them yet, but will use the cream I use for my eczema, the triamcinolone acetonide.
Information has been received from a certified medical assistant concerning a 31 month old male with no pertinent medical history and on known drug allergies who on 19-OCT-2010 was vaccinated subcutaneously in the left thigh with the first 0.5 ml dose of MMR II (lot# 664795/0442Z). There was no concomitant medication. On 27-OCT-2010 the patient developed a fever of 101.9 degree at night and had a rash over the "whole body" in the next morning. On 28-OCT-2010 the patient was seen at office and the physician "suspected the rash was measles". At the office visit on 28-OCT-2010 there was no fever detected and the rash was described as red raised rash over the entire body that was not itchy. At the time of the report, the patient's outcome was not recovered. No diagnostic laboratory tests were performed. Follow-up information from a physician's assistant indicated that the patient with no illness at time of vaccination received the vaccine at 1:00 PM on 19-OCT-2010. Onset of fever was at 1:00 PM, on 27-OCT-2010 with a rash all over body in the next morning. The patient was seen at office with a red blanching rash mostly on face, ears and extremities. Mild swelling was noted in feet and hands. The temperature was normal as 97.7 axillary. Additional information is not expected.
Infanrix administered to a 11 y/o patient; Received Infanrix instead of Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received DTPa (Infanrix) (batch number 49TM, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th August 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 17th August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's comment: Healthcare Professional (HCP) reported that while the patient was 11 years old, the patient had received the Infanrix instead of the Boostrix. No reactions were reported. The vaccine administration facility was the same as primary reporter. The reporter had consented to follow-up by email. Additional supportive information: A 11 years old patient had received Infanrix instead of the Boostrix which led to inappropriate age at vaccine administration and wrong vaccine administered.
Pt stated she took a nap and when she woke up her arm was swollen and warm to the touch. She came and showed me on Friday and she received her shot on Wednesday. Her arm was swollen past her elbow, red, and warm to the touch. Pt stated that her hands had swollen and she had to remove her rings and it felt like the swelling was slowly going down her arm. Stated that it was going down but she wanted to check on it. Told pt to take some BENADRYL and TYLENOL and it should go down but to call me back if it did not.
1-2 drops rolled down and vaccine leakage out of the patient's arm; she did not get the full dose; A spontaneous report was received from a pharmacist concerning an elderly (over 65 years old), female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 1-2 drops rolled down and vaccine leakage out of the patient's arm and she did not get the full dose.  There were no medical history and concomitant medications reported.  On 19-Jan-2021, the patient received the first of two planned doses of mRNA-1273 intramuscularly in the left arm using one-inch needle for prophylaxis of COVID-19 infection and one or two drops rolled down and leaked out of the patient's arm in which she did not get the full dose.  The pharmacist reported that the patient tolerated vaccine well.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events "1-2 drops rolled down and vaccine leakage out of the patient's arm and she did not get the full dose" was recovered.; Reporter's Comments: This concerns an elderly female patient who received the first of two planned doses of mRNA-1273 (lot# 028L20A) intramuscularly in the left arm using one-inch needle for prophylaxis of COVID-19 infection and experienced one or two drops of the vaccine leakage out of the arm and did not get the full dose.. There were no reported adverse events associated with this event of one or two drops that rolled down and vaccine leakage out of the patient's arm and felt she did not get the full dose.
Fever up to 100 degree F; Severe back pain radiating to bilateral flank. Moderate back pain with bilateral flank pain; Severe back pain radiating to bilateral flank. Moderate back pain with bilateral flank pain; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Sep2021 12:00 (Lot number: FC 3181) at the age of 51 years as dose 1, single for covid-19 immunization.   Relevant medical history included: "Thyroid nodules" (unspecified if ongoing), notes: Thyroid nodules; "HTN" (unspecified if ongoing), notes: HTN. The patient's concomitant medications were not reported.  The following information was reported: PYREXIA (non-serious) with onset 14Sep2021 16:00, outcome "not recovered", described as "Fever up to 100 degree F"; BACK PAIN (non-serious), FLANK PAIN (non-serious) all with onset 14Sep2021 16:00, outcome "not recovered" and all described as "Severe back pain radiating to bilateral flank. Moderate back pain with bilateral flank pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, back pain, flank pain.  Additional information: The reporter is a nurse (patient). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Tylenol for the event, but it was not resolving the problem. She was not diagnosed with COVID-19 prior to vaccination prior to vaccination and had not been tested for COVID-19 since the vaccination. Her allergies were reported as none.  No follow-up attempts are possible. No further information is expected.
Patient was seen walking down hall a few minutes after receiving her vaccinations and complained to a staff member she was feeling lightheaded and nauseaous. Staff member promptly alerted someone who assessed patient as having a vasovagal reaction. Patient signs/symptoms included lightheaded, nausea, diaphoresis, unsteady gait. Pt denied shortness of breath, dyspnea, swelling of lips, mouth, or throat, difficulty swallowing, or itching of vaccination site. Pt was promptly seated in physical exams and was reassured this was a simple vasovagal reaction that's very common after which the patient reported this had happened 5 years before after receiving a flu vaccination. Pt was given a bottle of water and some food while she remained seated under observation. Pt recovered completely with complete resolution of symptoms and no further evaluation was needed. Patient finished readiness processing in the clinic and was cleared Annotation was made in her health record of vasovagal reaction.