chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's Thyroiditis" (unspecified if ongoing). Concomitant medication(s) included: LEVOXYL and Thryroid Hormone. Past drug history included: Biaxin, reaction(s): "known allergies". The following information was reported: VACCINATION FAILURE (medically significant) with onset 14Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 14Jun2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10May2022) Positive, notes: On 10May2022, I once again became symptomatic and remained symptomatic and positive through 14Jun2022; (07Jun2022) Negative, notes: through 09Jun2022; (14Jun2022) Positive; (15Jun2022) Negative, notes: On 15Jun2022 I once again tested negative and have remained so. Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient began Paxlovid on day 1 of her covid illness, 30May2022. She completed the dose and tested negative via RAT on 07Jun2022 through 09Jun2022. On 10May2022, patient once again became symptomatic and remained symptomatic and positive through 14Jun2022. Symptoms were more severe than initial illness and included fever, headache, congestion, cough, sneezing, fatigue. On 15Jun2022, patient once again tested negative and have remained so.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.
Possible late dose, more than 6 months; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Possible late dose, more than 6 months). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 20-Apr-2023 The physician reported that possible late dose of Shingrix greater than 6 months. No additional adverse event details were available. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
INC # CAMVU- 2021004313.  Patient complained of dizziness with associated nausea post second dose of Moderna.  Patient was assessed by Paramedic ambulance and AMA with local MICN. MODERNA COVID 19 EUA
Patient came into the store to report swollen red arm that was approximately half her arm. The swollen was hot to the touch. This started approximately the day after the vaccine. The injection site was very low on the arm.
Flu like sx, ichy eyes, cough, hard to breathe, congestion, chest ache;
heart racing while taking the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart racing while taking the first dose) 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 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PALPITATIONS (heart racing while taking the first dose). On 06-Feb-2021, PALPITATIONS (heart racing while taking the first dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
Had first dose of COVID vaccine Wednesday 3/24 Thursday started with chills , could not get warm , slight nausea, headache 10/10 - took Excedrin and that helped  Friday same symptoms as Thursday  but did vomit x 2  Afebrile  Has had headaches daily since vaccine but has managed them with Excedrin Saturday thought she was getting better, dizziness and nausea that started later in the day, slight chills  Sunday - nausea, dry heaves- , freezing all day  Was unable to keep anything down - tried crackers and water  Tried Dramamine due to the dizziness and nausea - helps a little  States she is still using Dramamine and it is helpful Monday and Tuesday still having waves of nausea and dry heaves States she is able to eat and drink and keep things down, and is "taking it easy with the food"  Stated constantly feels like a weight is sitting on her throat Describes as pressure, burning and feeling like a weight is sitting there constantly - area of the chin, down her throat to the breastbone in center of chest between her breasts Stated this has been present for 3 days and has been a constant feeling Rates this discomfort as 8/10   Patient referred for ER for assessment today
caused lymphodema on my right side. Lymph nodes removed in 2019 during unilateral masectomy
Chills,fever,severe body ache,jaw pain,dizzyness,nausea,vomiting.  Tylenol, meclizine for vomiting
Client came to the facility to receive her 1st dose of the Covid19 Moderna vaccine. RN vaccinated the client in the left arm at 13:38 with the Covid19 Moderna vaccine (Lot# 069H21A). However, RN inadvertently administered the incorrect dosage to the client. She administered a booster dose of 0.25 mL instead of a full dose of 0.5 mL. The error was discovered by Co-Lead RN's while performing a reconciliation of the available vaccine on the floor. Co-Lead RN's notified Lead RN immediately. Lead RN spoke with RN and determined the client had only received 50% of the full dose required for dose 1 of the Covid19 Moderna series. After consulting with Clinical Nurse Lead it was determined the client would need to return to the facility to receive another 0.25 mL injection of the Covid19 Moderna vaccine. Lead RN called the client at 14:09 and explained what happened. The client was very understanding, stating she would return to the facility to be re-vaccinated. By 14:340 the client had returned to the RN?s vaccination station, and the RN administered 0.25 mL of the Covid19 Moderna vaccine (Lot# 069H21A) into the client's left arm, an inch away from the initial 0.25 mL vaccination. Afterward, the client was directed to the observation area to sit for 15 minutes. No issues were noted.
This spontaneous report was received from a nurse regarding unknown number of patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients received unknown number of doses of M-M-R II  lot# M027637 with expiry date: 02-JUN-2018, lot# L040960 with expiry date: 16-OCT-2017 and lot# L003855 with expiry date: 05-FEB-2017 following temperature excursions to -1 C for 30 minutes and 9C for 13 minutes for prophylaxis (dosing details not reported). There was no previous temperature excursion. The call was due to data logger. No adverse effects were reported in any patients. No product quality complaint was involved.  This is one of the several reports due to the same reporter.  Additional information has been requested.
Got a rash on my neck and chest. Bright red, flat and itchy. Has happened to me before with medications like NyQuil etc but never a vaccine. Resolved within two days. Possibly my body?s way or responding, not sure
12 hours after 2nd dose, 103 fever, body aches, chills, headache for 48 hours. 24 hours-2 weeks after 2nd dose: Tachycardia/irregular heart beat/heart palpitations and extreme vertigo/brain fog. I work at an OBGYN and spoke with one of the NP's who gave me xanax for anxiety. States am having true heart palpitations but marked it off as anxiety.  ~1 month post vaccine: Still having issues with my heart beat. Headache and brain fog has not gone away since the vaccine. Now having a menstrual period 2 weeks early with extremely heavy cramping. Am currently saving money to try to see cardiologist. Have a referral for a neurologist.
Beginning one day after second shot, I experienced an intense ringing in my left ear and continues to this day. In addition 5 days after the second shot I experienced a heavy pulsing with intermittent pain on both the left and right side of my neck for a week. This symptom stopped after a week.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On or about 22-MAR-2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration unknown), as recommended for routine adult health maintenance and the prevention of shingles. It was reported that the vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 15-SEP-2016, the patient was treated by a physician for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster involving dermatome. On or about 01-FEB-2017, the patient was treated again by a physician for ongoing and worsening symptoms, diagnosed as herpes zoster cervical dermatome.  The patient has been prescribed valacyclovir hydrochloride (VALTREX), prednisone, and tramadol hydrochloride (TRAMADOL) for the management of her painful and persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical center treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain suffering, and other damages. Upon internal review, worsening symptoms diagnosed as herpes zoster cervical dermatome has been determined to be medically significant. Additional information has been requested.
Wheezing; Lightheaded; Fever; Sore arm; Chills; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING, DIZZINESS, PYREXIA, VACCINATION SITE PAIN, and CHILLS in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Cholesterol high. Concomitant products included INLYTA for Lung cancer.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced WHEEZING, DIZZINESS, PYREXIA, VACCINATION SITE PAIN, and CHILLS. On 24-Feb-2021, WHEEZING, DIZZINESS, PYREXIA, VACCINATION SITE PAIN, and CHILLS had resolved.            Treatment information not provided
pt reports racing heart, weakness, dizziness & chills lasting 4hr;pt reports recv shot @ ER which relieved sx;
small knot at shot site, 1 day post shots. Significant swelling and erythema of left thigh on second day. erythema spread along the lateral side to slightly below the knee and 3/4 of the way up the thigh. Rx: Ketler 250/Scc, 1/2 tsp QID x 7d
Got a real back problem; This is a spontaneous report from a contactable consumer report for self. This 74-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated between his first and second dose of the vaccine he got a real back problem and took drugs and is on the final course of prednisone. He stated today (as of 21Apr2021) is day 41 after the first dose so he has 24 hours to get the second shot. The event outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Around 10:38 AM patient arrived with her parents and sibling, all four were in the same car and all were vaccinated, RN vaccinated Pt age 12 with a Pfizer Pedes dose. She did verified with the parents all the identifiers, Name, Age and DOB. however the confusion started when the car pulled up with the wrong color laminated Pfizer sheet. her younger sibling did received the proper vaccine and so did the parents. Before calling the parents I spoke with doctor to see what options we had. since the child just turned 12 this past October we did not under dose I was unable to get ahold of the parents and I left a detail voice message so they could call me back as of 19:30 they have not called me back.
Pain began in the right sciatic, moved across my lower back with extreme pain, into the left sciatic and down the left leg which caused the left foot to go numb and tingly for 10 days. Leg ached pain level 9 and keeping me up at night with the extreme pain. Left hip was so bad I could not walk safely. That lasted about a week. the pain traveled into my left arm and scapula, causing pain in the left arm and making the left hand numb and tingly, also level 8 pain in the left arm, lasting about 10 days. The pain has settled in my right arm, right shoulder and scapula, down the arm causing spikes of level 10 pain and the right hand is numb and this has been for the last 3 weeks.
A couple hours after administration, patient claims the injection site and surrounding area became red and itchy. Area covered about a two inch diameter around injection site.
felt like he had the flu.; headache; body aches; Has body chill; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like he had the flu.), HEADACHE (headache), MYALGIA (body aches), CHILLS (Has body chill) and FATIGUE (fatigue) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AB21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CLOPIDOGREL, RAMIPRIL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ATORVASTATIN for an unknown indication.    On 31-Mar-2021, the patient received second  dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date , the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown ) 1 dosage form. On 31-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like he had the flu.), HEADACHE (headache), MYALGIA (body aches), CHILLS (Has body chill) and FATIGUE (fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (felt like he had the flu.), HEADACHE (headache), MYALGIA (body aches), CHILLS (Has body chill) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
REDNESS AROUND INJECTION SITE, SWELLING AND WARMTH STARTED WITHINT 24 HOURS AFTER INJECTION, NOTICED BY MOM 24 HOURS LATER.  MOM CALLED ME THE FOLLOWING DAY, SYMPTOMS NOT WORSENING AND NO SIGNS OF FEVER OR RESPIRATORY INVOLVEMENT.  CONSERVATIVE-COMPRESSES, ORAL PAIN CONTROL MEDICATION AS NEEDED OR BENADRYL.
Hives around (R) eye, hives to (L) side of face and neck. Pt given CLARITIN. Signs/symptoms resolved.
I had no feelings whatsoever. I went to see my doctor for a dexa scan and it was discovered I had twenty five percent bone loss as of the last scan.
The day I got my injection I started my period and it was the heaviest and the worst cramps I have ever had in my life. Ive had two kids and these rivaled contractions. The second day I spent about half of my day just laying in bed trying to but some pressure on my cramps so they didn't hurt so bad.   I believe the first shot threw off my cycle and I was about a full week late for my period by the time I got my second shot. My periods aren't super regular so that isn't so out of character but I can handle a lot of pain and this was more than ive felt in a long time. Im 3 days out and today I woke up with normal menstrual pain and still heavy bleeding. But was able tp function normally.
Nervousness; Anxiety; Severe yeast infection; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (Nervousness), ANXIETY (Anxiety) and FUNGAL INFECTION (Severe yeast infection) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NERVOUSNESS (Nervousness), ANXIETY (Anxiety) and FUNGAL INFECTION (Severe yeast infection). At the time of the report, NERVOUSNESS (Nervousness), ANXIETY (Anxiety) and FUNGAL INFECTION (Severe yeast infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications and treatment  were reported.
24 Hours after shot got slight aches and low grade fever.  Lasted 20 hours.  Also had soreness in left arm where shot was given.  Soreness is nearly gone after 48 hours
Typical soreness at injection point, went away 1 day; left arm especially hit with arthritis pain, lasted 2 days but also pain up into neck area to present date (4-21-21).  Sore jaw approx. 5 days later along with body aches.  Sore throat - felt like lumps both sides of esophagus.  Severe dizzy spells ... first started on 04-11-21, was coughing and became extremely light headed, blackness, and eyes felt as if in some sort of seizure - as if vibrating at accelerated speed - nearly passed out.  Have experienced similar dizzy spells, less the seizure like symptom, since that time, generally brought on during coughing (which I have the 9/11 Rescue Workers 'WTC' cough).
Within a half an hour post vax, the pt experienced a slight metallic taste in her mouth. Reportedly by 10/30 the taste was very strong, like sucking on a rusty spoon.
no adverse event; patient was administered with an improperly stored dose of VARIVAX; This spontaneous report as received from a registered nurse refers to a 4 year old patient. On 15-SEP-2021, the patient was vaccinated with an improperly store dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U010400 exp date 01-APR-2023) (dose and route not reported). The vaccine experienced an excursion of (4°C) for 20 minutes on 07-SEP-2021 during transport and (4°C) for 20 minutes on 09-SEP-2021 during transport.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2109USA005628: US-009507513-2109USA005910: US-009507513-2109USA005742: US-009507513-2109USA005891: US-009507513-2109USA005964: US-009507513-2109USA005651: US-009507513-2109USA005918: US-009507513-2109USA005744: US-009507513-2109USA005648: US-009507513-2109USA005758: US-009507513-2109USA005628: US-009507513-2109USA005776: US-009507513-2109USA005901: US-009507513-2109USA005639: US-009507513-2109USA005662: US-009507513-2109USA005752: US-009507513-2109USA005641: US-009507513-2109USA005945: US-009507513-2109USA005618: US-009507513-2109USA005760: US-009507513-2109USA005881: US-009507513-2109USA005902:
Patient was diagnosed with a RLE Deep Vein thrombosis July 2021, 4 months after her initial covid vaccination series. She received treatment. Then got her booster 12.1.2021 and got diagnosed with another DVT 2.3.2022
Swollen Lymphnodes in Collarbone, sore, proceeded to get more swollen as days went by.
Moderna vaccine (NDC 80777-0273-98) lot #039D21A and GTH 00380777273983 was administered after the beyond date of 10/23/2021. Contacted manufacturer Moderna = no need to repeat the dose.
I received my vaccine on Sunday March 7 and in the morning of March 12, I woke up to a large bruise with a hard clot on the inside of my right forearm measuring 7cm x 4cm with a large clot in the bruise. I also have a smaller spot which has a firm bump under the skin. I did not hit my arm or injure it during my sleep or before going to bed.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. On an unknown date, the patients were vaccinated with VAQTA (dose, lot number and route not provided). No co-suspect or concomitant therapies were reported. The medical assistant reported that multiple unspecified patients were administered VAQTA that was improperly stored (dates not specified). No adverse effects were reported. This case is linked to cases 1406USSA008435, 1406USA008522, 1406USA008523, 1406USA008524 and 1406USA008525 (same reporter link). Additional information has been requested.
Patient felt lightheaded after 10 mins after administration of vaccine. Gave juice and crackers, he laid down for 10 more mins, took BP-within normal range, felt fine and left after 10 mins.
After feeding, vomited all her food at 1:30pm and then again at 3:50pm.
After 7 days of receiving the vaccine I started noticing an itchy/burning feeling at the site of the injection. As the day progressed the site feels uncomfortably itchy as well as swollen and red about an inch in diameter.  I applied hydrocortisone cream on it tonight and I'm still feeling the burning/itchy feeling. It is also painful to the touch. This is only the first day.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. It was reported that in August 2009 (also reported as "5 years ago") the patient was vaccinated with the first dose of GARDASIL (dose, route and lot number were not reported). On 20-AUG-2014 the patient was vaccinated with a second dose of GARDASIL (dose, route and lot number were not reported). No adverse events were reported. Additional information has been requested.
On 4/2/01, the pt came to medical for a cut on his index finger to be taken care of. He was also given an IM dose of TD in right deltoid muscle. On 4/4/01, the pt came back to medical, complaining of allergic reaction to injection site with redness, warmth, edema, induration with tenderness. He also complained of dragging and heavy sensation to the area and his armpit.
Caller received his second COVID vaccine, yesterday 7:30 PM.  Awoke today with chills, headaches, fever and pain in arm.  Has been taking Tylenol for fever, however, his temp has gone  from 97, to now 101.0.  Last took Tylenol at 4:00 PM and chills are worsening.  Encouraged to seek care at ED for these symptoms.
Huge red swelling knot at injection site, feel like I have the flu .. headache muscle aches feel horrible.