chrisvoncsefalvay/vaers-outcomes huggingface dataset:
21aug90 pt vax hepta B. pt ex lihgtheadedness. pt reported being sick and did not work for next 2 days. 23aug90 pt reported that still felt lightheadedness, h/a, weakness, malaise, n/ and diarrhea.hypersens. react considered.  see worm
PT WAS DIZZY AND WEAK IN THE KNEES; SHE ALSO REPORTED FACIAL SWELLING AND NUMBNESS TO PHARMACIST.
The vial was initially stored in the refrigerator on 12May2022 expired on 02may22; We administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12May2022 expired on 02may22) in a 91-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12May2022 expired on 02may22). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12May2022 expired on 02may22) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported.
PT IMMEDIATELY EXPERIENCED "RUSHING" FEELING, AND THROAT TIGHTNESS, A LITTLE DIZZINESS. SYMPTOMS EXPERIENCED SEEMED TO WANE THEN COME BACK AFTER SEVERAL MINUTES. LATER STATED HER VISION STARTED TO GET IMPAIRED. PT WAS OBSERVED FOR ABOUT AN HOUR BEFORE LEAVING WITH FAMILY. DID NOT HAVE TO GIVE EPIPEN.
4JUN93 had 40" unconsolable crying-fever not verified w/thermometer sl difficulty in swallowing; 5JUN93 awakened w/face & eyes swollen in AM staring spells in afternoon; sl temp elevated treated w/APAP; dx cumulative reaction to DTP;
COVID test result positive; Slurred speech, difficulty putting thoughts to words in complete sentences; Slurred speech, difficulty putting thoughts to words in complete sentences; This is a spontaneous report from a contactable consumer (patient). A 15-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 14May2021 08:00 (Batch/Lot Number: EW0177.CCC-MN, as reported) (at the age of 15 years old) as 1st dose, single dose for COVID-19 immunization. The patient medical history was not reported. No known allergies. Concomitant medication included ibuprofen. No other vaccine in four weeks. Facility where the most recent COVID-19 vaccine was administered at Clinic. The patient experienced slurred speech, difficulty putting thoughts to words in complete sentences on 14May2021 08:30 and COVID test result positive on 18May2021. There was no treatment for the events. No COVID prior vaccination. The patient underwent lab tests and procedures which included PCR Saliva (COVID-19 test): positive  on 18May2021. The outcome of the events was recovered on unspecified date.
A report has been received from a Health Professional concerning a patient, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 03-Dec-2013. It was reported that patient was given expired FLUMIST QUADRIVALENT inadvertently to forty-two patients on 03-Dec-2013. The outcome of the event of gave expired FLUMIST is unknown. The report was considered to be non-serious.
Patient received a flu vaccine in her (R) arm. Days afterward she noticed an area of indentation high up on her arm where the shot had been administered. She saw a physician who told her the vaccine was administered too high up on her deltoid.
Large red area on right calf and rash on both legs.   Itching on palms of hands and bottom f feet
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a female of unspecified age race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose, frequency 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 08-JUL-2021, the patient and her daughter were tested covid-19 positive (suspected clinical vaccination failure and suspected covid-19 infection). Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210718648.; Sender's Comments: V0:20210720833- Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
fell off chair in the recovery area at approx 10:15 am shortly after vaccination, appearing to have fainted (vasovagal reaction). Recovered quickly, was speaking to staff within seconds after faint. Was assessed by EMS who were onsite.  BG was found to be low at 48 (had not eaten prior to vaccine). BP 133/88 and 136/90, pulses 130 and 120 30 min apart.  After juice/light snacks, BG came up to 112 and he felt much better.  Advised to follow up with health care provider as needed.
Massive nose bleed with a huge blood clot to follow.  Went to urgent care but it had stopped by then so they sent me home and told me if it happened again to go to ER.  I haven?t had a nosebleed in years so it was scary to get it the day after my vaccine.  The nose bleed lasted about 10 minutes and was very strong once the clot came through it slowed down and then stopped and did not return again.
Felt lightheaded and dizzy for 30 seconds. EMS was called due to previous allergic reaction. Blood pressure was low (78/60). Typical blood pressure for patient is 115/80. He had no hives, angioedema, shortness of breath, vomiting, or diarrhea. Symptoms resolved without treatment and he did not require transport.
I went in for a doctor's appointment. They did an echocardiogram and a stress test. I was advised that my heart had weakened. I believe it was about 305. They completed a catherization and did not find anything treatable. The put me on Carvedilol and Entresto and the cardiologist referred me to an electrophysiologist. I had a pacemaker implanted on March 22, 2023.  I am still recovering. I saw my doctor for a check up on Wednesday the 29th and everything looked okay.
NO ADVERSE EVENT NOTED, BUT VACCINE SCHEDULE NOT CORRECT. PATIENT HAD RECEIVED A J&J VACCINATION ON 3/20/2021 FROM ANOTHER PROVIDER.  WHEN HE CAME TO OUR PHARMACY, HE DID NOT REQUEST A BOOSTER, HE SAID HE NEEDED PRIMARY MODERNA SERIES.  TWO FULL DOSES WERE ADMINISTERED INSTEAD OF BOOSTER DOSE.  HE RECEIVED ONE ON 8/30/2021 AND THE SECOND ON 9/29/2021.
Narrative: Patient contacted clinic to report fever, muscle pain, joint pain, fatigue, and swollen, sore lymph nodes following following second dose of Moderna  COVID19 vaccine. Reported that symptoms resolved in 36 hours. No treatment documented.
An ASPP who rec'd from the MCA regulatory authority on 2/18/02 concerning a pt of unknown age who was hospitalized for facial palsy, altered sensation, and paraesthesia after receiving an influenza vaccine on 11/3/01. The pt also rec'd  bacillus pneumococcal vaccine on 1/12/01. In 11/01, the pt developed possible Guillain Barre Syndrome, facial palsy, paraesthesia of the limbs and feet and altered sensations on the feet leading to hospitalization in 1/02. The outcome is not known. There was insufficient information to determine the reporters causality assessment.
Received ZOSTAVAX (varicella zoster vaccine by Merck) subcutaneously in right arm at 10pm 8/11/14. On 8/13/14 and 8/14/14 felt and observe significant erythema (redness, heat, mild itching) in injection area approximately 1 inch by 1.5 inches in size.
Information was received from a pharmacist regarding a 25 year old male patient. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On 29-JUN-2017, the patient inadvertently received an expired dose (lot # L001312; expiration date 24-FEB-2017) of GARDASIL 9 intramuscularly. He also received GARDASIL 9 (lot number, expiration date not provided) on 19-APR-2017. No adverse events were reported. No further information was provided. The outcome of the events were unknown. Additional information has been requested.
2nd vac on 3/27/21.  On 3/29/21 called  Vacination site to report having tinnitus occuring approximately 24 hours after rec 2nd dose vacination. History of tinnitus, no immediate reaction reported day of vac. No complaints reported  from 1st dose 3 weeks prior. Pt reported symptoms have diminished but not completely gone due to having hx of tinnitus. Advised to call primary if symptoms worsen. Provided reassurance.  No other complaints. Advised about  site.
my arm was swollen and tender; cold sweat; crust in both eyes; painful eye / sting in my eyes; loss of appetite; has not received the second dose >42 days; rash on my left arm; headache; pain in her joints; arm tender / pain in my calf; chills; fatigue; terribly ill for 2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (terribly ill for 2 weeks), PERIPHERAL SWELLING (my arm was swollen and tender), COLD SWEAT (cold sweat), EYELID MARGIN CRUSTING (crust in both eyes) and EYE PAIN (painful eye / sting in my eyes) in an 85-year-old female patient 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 04-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 ILLNESS (terribly ill for 2 weeks), PERIPHERAL SWELLING (my arm was swollen and tender), COLD SWEAT (cold sweat), EYELID MARGIN CRUSTING (crust in both eyes), EYE PAIN (painful eye / sting in my eyes), DECREASED APPETITE (loss of appetite), PRODUCT DOSE OMISSION ISSUE (has not received the second dose >42 days), RASH (rash on my left arm), HEADACHE (headache), ARTHRALGIA (pain in her joints), MYALGIA (arm tender / pain in my calf), CHILLS (chills) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ILLNESS (terribly ill for 2 weeks) and PRODUCT DOSE OMISSION ISSUE (has not received the second dose >42 days) had resolved and PERIPHERAL SWELLING (my arm was swollen and tender), COLD SWEAT (cold sweat), EYELID MARGIN CRUSTING (crust in both eyes), EYE PAIN (painful eye / sting in my eyes), DECREASED APPETITE (loss of appetite), RASH (rash on my left arm), HEADACHE (headache), ARTHRALGIA (pain in her joints), MYALGIA (arm tender / pain in my calf), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported by the reporter.
Intense soreness/pain in muscles ( arms, under breasts rib area, thighs, lower legs and  ankles), blood in urine,  pain in all major joints.  difficulty walking and limited range of motion. Symptoms showed up after 7 days after vaccine was received. Presented to urgent care after test were don't I was hospitalized  inpatient  for 4 days. I was diagnosed with RHABDOMYOLYSIS,  ABNL LIVER FUNCTION STUDY.  CREATINE KINASE TEST OUTCOME WAS AT 41000.
Complete Heart Failure. No pulse, Not breathing, Non-Responsive. Primary symptom: Dead Treatment: A cardiologist and an ICU nurse were playing Ice Hockey with me and they used a portable defalcator to bring me back to life. I was dead for approximately 7-10 minutes
Red raised rash on left arm and chest, itching. 12/4/09 ER records received for date 10/23/09. DX: urticaria. Presenting c/o: hives, itching, rash after flu vax on 10/21/09. Assessment: diffused rash.
Ringing of both ears, dizziness, headaches, body aches, temp 99.1, injection site soreness, nausea , fatigue.
Patient received booster 11 days early of the 6 months.  Looked at the shot dates incorrectly - looked at the first shot of 4/29/21 instead of the 5/20/21.
This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced COVID on an unspecified date. Caller also asked if should get the 2nd dose after 42 days from the first dose since they both had COVID. Caller stated that recovered from Covid-19 two weeks ago and was wondering when they can get the Pfizer BioNTech Covid vaccine. She stated that they did not have the monoclonal antibody treatment and was not admitted in the hospital instead just at home. The patient underwent lab tests and procedures which included sars-cov-2 test positive on an unspecified date. The outcome of events was unknown.  Information on the lot/batch number has been requested.
PT SAID SHE WAS FINE AFTER FIRST VACCINE AND WAS FINE RIGHT AFTER SECOND VACCINE, BUT THEN WENT HOME AND HAD A SANDWICH AND WHILE SHE WAS EATING ABOUT AN HOUR AFTER HER THROAT STARTED TO CLOSE UP.  SHE WAS VERY SCARED.
Developed local reaction. Skin had a red, hot and swollen area 3.5cm X 5cm at site of injection.
Extremely sore throat. Headache, post nasal drip, body ache, mild sweating and chills. Developed a cough the next day. Developed hoarseness with partial loss of voice on day 2 and 3.
I have a  super swollen lymph node on my left side - neck- throat. I felt like I have a really bad case of mono or in a bad flare of lupus.  Headache, fatigue, sore throat ,throat pain, ear pain and general feeling of ill. Felt better on June 19th and 20th. However on 21st and 22nd sore throat and a lot of drainage  along with a temperature appearing on the 22nd. I thought it was getting better however lymph node is still swollen and now I have a low grade fever that is 100 with Tylenol.
fever of 101.6, & loss of appetite; also exp rash; APAP given;
Woke up with hive-like rash on abdomen and upper legs. Received 1st dose of Pfizer on 4/22. Recommended calling PCP.
Initial unsolicited report received from a consumer (patient's wife) on 31 March 2015. A male patient, whose age, medical history and concomitant medication were not reported, had received a dose of Flu Vaccine (batch number, expiration date, route of administration, dose and dose cycle were not reported) in arm on 30 March 2015. On 30 March 2015, few minutes after vaccination patient's arm got very tender and painful to touch from the site of administration down to his elbow. Laboratory investigation and corrective treatment were not reported. At the time of this report, outcome of event was not recovered. List of documents held by sender: none. Follow-up information received from a non-healthcare professional on 14 April 2015. A 36-year-old male patient was vaccinated with a dose of Flu Vaccine. Corrective treatments, medical history and laboratory investigations were reported as none. At the time of this report, the outcome of the events was reported as recovered on the same day of vaccination. Documents held by sender: none. Follow-up information received from a consumer on 14 April 2015. It was reported that the patient had increased pain with arm movement same day as vaccination. Concomitant medications, risk factors, medical history, relevant laboratory and diagnostic tests and treatment information reported as none. On an unknown date, the patient recovered from the event. Documents held by sender: none.
Information has been received from a registered nurse concerning a 62 year old patient who was inadvertently vaccinated with a dose of Varivax. The patient was supposed to have received Zostavax. The person administering the vaccine thought it would protect the patient against shingles. Unspecified medical attention was sought. A product quality complaint was not involved. No further information is available.
I experienced body aches then chills and then started sweating profusely, followed by vomiting x1 hour. I felt very weak for about a day afterwards, then was fine after that.
Light perception seemed to be diminished to 50% one day after vaccine/Visual; felt chills; slight fever; headache; general feeling of malaise/I also felt general malaise for two days.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Sep2021 16:45 (Lot number: FF8839) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL. Vaccination history included: Bnt162b2 (Dose 1, Single , Batch/Lot No: EJI685, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 29Dec2020, when the patient was 48 years old, for COVID-19 immunisation; Bnt162b2 (Dose 2, Single , Batch/Lot No: ELI283, Location of injection: Arm Left, Vaccine Administration Time: 08:30 AM), administration date: 19Jan2021, when the patient was 48 years old, for COVID-19 immunisation. The following information was reported: VISUAL IMPAIRMENT (non-serious) with onset 29Sep2021 19:00, outcome "recovered", described as "Light perception seemed to be diminished to 50% one day after vaccine/Visual"; CHILLS (non-serious) with onset 29Sep2021 19:00, outcome "recovered", described as "felt chills"; PYREXIA (non-serious) with onset 29Sep2021 19:00, outcome "recovered", described as "slight fever"; HEADACHE (non-serious) with onset 29Sep2021 19:00, outcome "recovered", described as "headache"; MALAISE (non-serious) with onset 29Sep2021 19:00, outcome "recovered", described as "general feeling of malaise/I also felt general malaise for two days.". Therapeutic measures were not taken as a result of visual impairment, chills, pyrexia, headache, malaise.  Additional information:  the patient reported After vaccination in the evening of same day Light perception seemed to be diminished to 50% one day after vaccine. Additionally, felt chills, slight fever, headache and general feeling of malaise.Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.  Follow-up (27Oct2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported in response to Non HCP letter sent that included:  Follow-up attempts are completed. No further information is expected.
Fever, vomiting, headache over last 5 hours. Treatment so far is Advil and fluids.  Dr visit later today.
SIDE EFFECT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced side effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effect was not reported. This report was non-serious.
pain at injection site 2 days later. No s/s of infection or erythema. No treatment needed
Myalgia, Fever & NauseaVomiting Narrative:  7/30/21 recieved #1 dose, for 2 d low grade fever and body aches, uneasy stomach. Has already returned to work on 8/2/21
Paralysis from left arm down to feet; Unbearable pain; Could not walk; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PARALYSIS (Paralysis from left arm down to feet) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARALYSIS (Paralysis from left arm down to feet) (seriousness criterion medically significant), PAIN (Unbearable pain) and GAIT INABILITY (Could not walk). At the time of the report, PARALYSIS (Paralysis from left arm down to feet), PAIN (Unbearable pain) and GAIT INABILITY (Could not walk) outcome was unknown.        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.   Concomitant product use was not provided.  Treatment information was unknown.  Company Comment: 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.; 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.
Severe allergic reaction: nasal and throat congestion, mild fatigue, productive cough, sneezing  Lasted 10-12 days. No fever, no nausea
diaphoresis;tiredness;swollen rt arm;redness @ inj site;body aches;
Patient received both vaccines and then began to faint and shake.  Spoke to patient until she regained normalcy and then laid her back and elevated her feet. Provided patient with lollipop and an ice pack. Checked patients blood pressure and observed her for 15minutes. once she was feeling better she was able to go home.
Vivid dreams and cant sleep, Insomnia, hallucinations, numbness, tingling, facial flushes, rashes, gut issues, heart racing and palpitations, high blood pressure, weight loss,
On 10/16/17, patient reported that on the evening of her PNEUMOVAX vaccine, 10/14/17, her arm became really sore. She could not raise her arm. The site of vaccination was swollen, bright red, and hot. She reported soreness from her armpit and collarbone as well. She applied ice and took BENADRYL, which seemed to help. By Monday, 10/16/17 her symptoms were not better and went to see her doctor. She reported to us that she had an infection at the site of vaccination.