chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sweating; Chills; AFIB; Heart rate racing; Lightheadedness and dizzy and felt like she would pass out.; Nausea; Muscle ache; Headache; Second dose arm hurt at injection site; compromised immune status; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), intramuscular at arm left on 13Feb2021 at 10:30 (at the age of 74 years) at single dose for COVID-19 immunization.  Medical history included primary biliary cholangitis (PBC, autoimmune condition and was diagnosed 10 years ago), diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, diabetes and obesity, all from an unknown date and unknown if ongoing.  There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), intramuscular at arm left on 24Jan2021 and experienced sore arm. The patient experienced headache and arm hurt at injection site, both on 13Feb2021 at 19:00; heart rate racing, AFib, lightheadedness and dizzy and felt like she would pass out, all on 14Feb2021 at 07:30; nausea, muscle ache, both on 14Feb2021 at 03:00, chills on 14Feb2021 at 15:00 and sweating on 14Feb2021 at 16:00.  The patient outcome of the events was recovering.
Headache, fatigue, nauseated, dizzy, fever, pale - after dose #2. Had severe arm pain for greater than 1 week after dose #1.
Patient is reporting a bruised feeling, a dull pain, with weakness in left arm at vaccination site.  Began in late May.  Is intermittent 2-3 times a week for 2-4 hours at a time.
Rt. arm: sore arm x about 3 days. Area above elbow - tender, bruises (dark reddish) (2 - on inside of arm above elbow). Also taking Aspirin still sore. Advised pt. to see MD if soreness persists, or gets worse.
extremely blurred vision (both near and far), comes and goes, started approximately one week after second dose of COVID vaccine.
large redness swollen area on lt upper arm; size of soft ball; tender to touch; hot to touch; no fever-temp nl;
Vaccines given at 8:30AM. Mother reports child developed rash 10:30AM. Mother gave PO Benadryl 11:00. Pt returned to clinic, child has red, raised rash and itching all over, no resp distress.
Case number PHEH2016US023488, is an initial spontaneous report from a consumer received on 12 Sep 2016. This report refers to a 43 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with one single dose of expired FLUVIRIN (batch number: 157104) at a dose of 0.5 ml, intramuscularly on 12 Sep 2016. It was stated that, expired vaccine was administered to 05 patients on 12 Sep 2016. No adverse event was reported following this medication error. The case was assessed as non-serious by the consumer.
12/7/10 Redness, swelling in left deltoid within 15 minutes after injections. 12/7/10 Leg spasms Wed. evening. 12/9/10 Muscle spasms - entire body per mom taken to Urgent Care - given antibiotics 12/14/10 Follow up with M.D. - improving.
Palpitations, restlessness, stomach discomfort pharyngeal edema, headache, dizziness, chest pain, decreased blood pressure. 7/28/08-death certificate received; COD:respiratory failure. Chronic obstructive pulmonary disease.
Has received Flu vaccine in the past with no problem.  At 10pm, had achiness on joints and broke out with very itchy hives on chest and back.   Took 50mg of Benadryl, called doctor and told to go to ER.   At ER, no testing done, given choice of steroid or Benadryl; patient choose Benadryl and it did help. Patient was not admitted to hospital.  Next day patient felt terrible; symptoms included: muscular aches, fatigue with exertion, hives settled down but skin was still burning and tender to touch.    Patient went to pharmacy on 10/16 to report problem and get vaccine packet insert for reference.     Patient feels much better today--at 85 % recovery.    Daughter is pharmacy student and mentioned that the other patients had similar problems.   County health department also mentioned to wife that they were not administering that vaccine since problems were reported.
Information has been received from a physician concerning a 25 year old female who on an unspecified date was vaccinated with HPV Vaccine. One week later, the patient was noted to have a positive human papilloma virus infection (date unknown). It was reported that the physician dose not know when the vaccine was given or the dose because she did not administer the vaccine in her office. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered from the event. Additional information has been requested.
Eczema on cubital fossa and surrounding area on inside arm (opposite of elbow) redness, spotting, itching, change of pigmentation or "pinking" of pigmentation symptoms are continuing to exist as of now.  Starting a daily regimen of hydroxyzine 25mg and desonide cream .05% (too early to tell results)
Psychosis; Pain in the back of eyes; Weakness; Chills; Muscle pains/ Myalgia; A spontaneous report was received from a consumer concerning a male patient of an unknown age who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed psychosis, pain in the back of his eyes, chills, myalgia, and weakness.   The patient's medical history included schizoaffective bipolar disorder. Products known to have been used by the patient, within two weeks prior to the event, included paliperidone.   The patient received their first of two planned doses of mRNA-1273 (batch number not provided) on 24 Dec 2020. On 21 Jan 2021, an unknown amount of time prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   On 27 Jan 2021, the patient received paliperidone.  On an undisclosed date, the patient experienced pain in the back of his eyes, felt a chill, muscle pains, and weakness. The patient had been diagnosed with schizoaffective bipolar disorder and was missing at the time of the report. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable because the patient had received both doses.   The outcome of the events psychosis, pain in the back of his eyes, chills, myalgia, and weakness, was not reported.; Reporter's Comments: This case concerns a male patient of an unknown age who experienced a medically important event of psychosis, and in addition non-serious events of pain in the back of his eyes, chills, myalgia, and weakness. Based on the current information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded, however the patient's history of schizoaffective bipolar disorder is a strong confounder for the event of psychosis. The case is lost to follow-up as Consumer did not give consent to follow-up.
?Covid arm? large red lesion around the vaccine injection site which is itchy then painful. Tinge long in right side of face.
It exactly started 15 minutes after the shot when my left arm which is the site of injection swallowed with great amount of pain. I slept that night which is 11/26/2021 at 8 pm with 3 softgels of advil 200 and 2 tablets of tylenol 500. today's date is 1127/2021 while i am writing this adverse event complaint. Since this morning.at 6:00 am when  I woke up, I have been dealing with a headache that I swear as a grown 29 year old male to the only one god that is one hundred times worse than the headache i have had when I got my seconf moderna shot six months ago. i can barely open my eyes half open with great amount of pressure and pain inside my eyes. My body is totally numb with great amount of pain while my legs are shaking,numb fingers and toes, toothaches and Nasea and vomitting to the point i can not rest at all. The first dose that i got moderna vaccine shot was 04/08/2021 with very minimal side effects. the second dose that i got was 05/04/2021 with also very minimal side effects. they said each dose was 0.5 for a total unit of 1. this last one was 0.25, and my total side effects was a 3 on a scale of 1-10. since i got my shot yesterday at 5 pm, my side effects is at 100 on a scale of "1-10 and above". If i knew this would happen, I would have never ever recieved this third low dose at any cost to anybody. They did not inform me for possible situation like this when i got my shot at the pharmacy. please make people aware because i will never get a fourth moderna shot or any other vaccine until I might die from covid. not again.
This is a spontaneous report from a contactable consumer. A male patient of an unspecified age (age: 67; unit: unknown) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 10Mar2021 as dose 2, single for covid-19 immunisation. Medical history included surgery, radical proctectomy, prostate cancer, allergy to contrast iodine dye, autoimmune disorder. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on unspecified date as dose 1, single for covid-19 immunisation. On an unspecified date, the patient experienced fever, difficulty getting out of bed, extreme stiffness throughout  the entire the body, loss of coordination, groin and pelvis pain, groin and pelvis pain, extreme general body pain, decrease hearing. Husband had surgery in January - radical proctectomy. Caller reported after second dose on March 10, husband spiked a fever. Husband has taken ibuprofen, Tylenol, and hydrocodone. Caller reported that she has called CDC, but they have not helped much. Caller reported that she had the vaccine and did not have a reaction. Caller would like to know if it could cause this severe of a reaction, and would Pfizer give vaccine if it could have this reaction. Caller mentioned Husband has allergy to contrast iodine dye. Caller reports suggested that her and husband get the vaccine. Caller reported that she has an autoimmune disease and her provider told her that she would not make antibodies to vaccine, but caller does not report any side effects. Caller stated that she would not recommend the vaccine to anyone. Caller stated that doctors do not know enough about the vaccine. Caller reported that she was not able to sign up with v-safe to report side effects post vaccine. Her husband was diagnosed with Prostate cancer in January. Since the 2nd dose her husband has been really sick and had not been able to walk. He was stiff all over. They were not sure if it is the Covid vaccine or if it was the cancer. She wanted to know if this has been reported before. Therapeutic measures were taken as a result of fever, difficulty getting out of bed, extreme stiffness throughout  the entire the body, loss of coordination, groin and pelvis pain, groin and pelvis pain, extreme general body pain, decrease hearing. The clinical outcome of events were unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Two days after vaccination patient developed sudden onset shortness of breath. He was sent to the hospital for a paracentesis related to a pericardial effusion on 12/7/21. Three days later the fluid has reaccumulated and he has now undergone a pericardial window. Patient states they were heading to restaurant and stopped at the store for their booster shot.
Missed second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose). On 30-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Missed second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Patient reported he missed his second dose on 30-Apr-2021 because his mother passed away and was still there due to travel restrictions at the time of this report.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Non Significant follow up
Two days after vaccine early morning fatigue felt during routine physical activity, mountain bicycle ride. Stopped bicycle ride, went home to rest. Next evening attempted another mountain bicycle ride and felt increasing chest pain. Decided to wait overnight to see if symptoms persisted, which they did. Visited emergency room next day at 14:00, complaint of chest pain and abnormal fatigue. Medical records are available for visit to hospital. To generalize, Troponin I High Sensitivity level of 187 pg/mL. Stayed overnight and had multiple studies of the heart.
Lymph glands were swollen; Headache; A spontaneous report was received from a healthcare professional regarding his coworker, female nurse ,who received Moderna Covid-19 vaccine and have experienced headache and swollen lymph glands.  The patient's medical history was not provided. Her concomitants were not provided. No information on allergies.   On 10-FEB-2021, prior to the onset of events, the patient received her first of two planned doses of Covid-19 vaccine for the prophylaxis of Covid-19 infection. On the same day, she felt headache and her lymph glands were swollen. She stayed overnight at the hospital for treatment.  Action taken with 2nd dose of Moderna Covid-19 vaccine was not reported.  The outcome of the events were unknown at the time of report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Patient (aRN ) felt dizzy was tachycardiac stayed in area for 1 hr symptoms persisted then was taken to ED  there was no evidence of Anaphylaxis is. Patient stateds she was given to large of dose RN administering denies states gave 0.5 IM  she was monitored for several hours because patient has cardiac history
I received the vaccine on 12/01/2022. By the next day around midnight I noticed a buzzing (ringing) noise in both ears that has progressed to constant ringing.
Rash on day #10, trurncal, 2-3 mm pink-red maculopapular lesions. No vesicles, no crusting approximately 20-25 cm.
bad taste in my mouth; leg tightness; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (bad taste in my mouth) and MUSCLE TIGHTNESS (leg tightness) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (bad taste in my mouth) and MUSCLE TIGHTNESS (leg tightness). At the time of the report, AGEUSIA (bad taste in my mouth) and MUSCLE TIGHTNESS (leg tightness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient became light headed and dizzy 5 minutes after shot was given. Was moved to the floor in the safety position. Given orange juice ice packs and wet compresses as temperature was elevated. BP was monitored and reading 100/40 HR was 46bpm.
Erythematous plaques/rash starting one day after vaccine that worsened at day 7 to eyelid swelling
muscle pain; chills; nausea; feeling all of the adverse events; fatigue; soreness; soreness; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of VACCINATION SITE PAIN (soreness), the first episode of FATIGUE (fatigue), MYALGIA (muscle pain), CHILLS (chills) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) and CLONAZEPAM for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced the first episode of VACCINATION SITE PAIN (soreness) and the first episode of FATIGUE (fatigue). On 17-Apr-2021, the patient experienced MYALGIA (muscle pain), CHILLS (chills), NAUSEA (nausea), ADVERSE EVENT (feeling all of the adverse events), the second episode of FATIGUE (fatigue) and the second episode of VACCINATION SITE PAIN (soreness). On 19-Apr-2021, MYALGIA (muscle pain), CHILLS (chills), NAUSEA (nausea), the last episode of FATIGUE (fatigue) and the last episode of VACCINATION SITE PAIN (soreness) had resolved. At the time of the report, ADVERSE EVENT (feeling all of the adverse events) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.     This case was linked to US-MODERNATX, INC.-MOD-2021-089413 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089413:1st dose
patient inadvertently received DAPTACEL instead of ADACEL/ no AE; 10-year-old patient received DAPTACEL/ no AE; Initial information was received on 23-Aug-2021 regarding an unsolicited valid non-serious case from other healthcare professional and consumer/ non healthcare professional via call center via Medical Information (Reference number- 00736487).  This case is linked to case 2021SA281773(CLUSTER).  This case involves a 10-year-old female patient who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered and Product administered to patient of inappropriate age).  The patient's past medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.  On 30-Jul-2021, the patient received a first dose of 0.5 mL of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U6900AA and expiry date: 18-Nov-2022) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency same day).  It was reported, "2 patients inadvertently received DAPTACEL instead of ADACEL. Caller with question on whether a dose of ADACEL now needs to be administered. Caller also with question on when the patients will be due for a booster dose of ADACEL".  At the time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Redness and swelling on left arm below site of injection.  6cm x 6 1/2 cm area of erythema and firmness approx 4-5cm in diameter.
Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022; Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2022 at 11:54 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Feb-2022 at 11:54 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021, this vaccine was administered up until its manufacturing expiry date of 4 April 2022.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-542869 (Patient Link).
arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose in November 2019, refer case US2020002562.).   On 2nd January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and had arm soreness which lasted 2 days and has resolved. The reporter consented to follow up.
Baby has been screaming/crying for 4 1/2 hours since 4 month immunizations were given th AM.  Cry is high pitched cry (heard in background when speaking with Dad).  Advised Dad to take baby to ER immediately to be evaluated, he agreed.  Called on  07/14/05 to check on baby, parents did not take him to ER, he finally stopped crying at 8 or 9PM last night.
Second dose - Severe Chills, joint and muscle pain. Flu like symptoms. Only lasted 24hours was fine the next day. First dose I was fine
Employee received vaccination around 12pm, by 11pm that same night employee had chills so bad it took 5 blankets to get her warm. Employee also experienced headache, nausea, body aches, and fever of 100.6-101. Chills have subsided, but still has headache, body ache, and temp of 100.6, employee in bed.
The vaccine was beyond use per the Pfizer website as of 8/31/22. The vaccine was marked on the box with a 10 week use by date (10 weeks post receiving the vaccine from dry ice). As such, patient was administered a vaccine that was expired 3 days prior.