chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED  CLINICAL VACCINE  FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age of unknown race and ethnicity. 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, expiry: Unknown) dose, 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 an unspecified date, the patient tested positive for suspected covid-19 infection after getting vaccinated (suspected clinical vaccine failure). Laboratory data (dates unspecified) 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 covid-19 infection and suspected clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210703022.; Sender's Comments: V0: 20210703179 -Covid-19 vaccine ad26.cov2.-Suspected Clinical Vaccine 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.
Nausea immediately after injection for about 60 minutes; facial flushing and 99.7 degrees Fahrenheit temperature upon waking up the following two mornings for ~45 minutes. Fatigue and not feeling well for 36 hours after injection. Sever arm soreness the following day after injection.
More facial  hives with no presence to allergen. Happening several times a week if not several times a day. Use hydrocortisone cream and medication changed to Accolate.
03/18/21- ct called-reports developed fever (103 F) evening post vaccination, this am developed angioedema-self tx w/ Claritin, midday feeling much better, -PCP aware of s/s, no further tx at this time, - day 2 evening- low grade fever, slept 11 hrs, feeling 'great today'.  Hx anaphylaxis x2, 6-7th grade r/t aspirin, dx  salicylate allergy, has epipen. Hx chronic hives/angioedema that can last 5-7yrs, tx w/ steroids.   3/19/21- PCP aware of s/s, no further tx at this time, last evening (day 2) low grade fever, slept 11 hrs, feeling 'great today'
No adverse reaction after the vaccine, some days after I noticed that my heart was beating abnormally, I was aware of that, that had never happened before; it lasted on and off for a number of days. Then it went away. It was intense when it was happening, I did not seek medical care. I thought I should take care of this and talk to my doctor before taking the next vaccine, but then it went away, and I forgot about it.
Narrative:  67yo male patient died on 11/28/2021. Pt has not received medical care from this facility since 8/2018. Per MD note 2/2/2018: "PMH:==== Prostate CA 1999 Compression fracture to ankle Bilateral knee pain with blast injury Ventral hernia Lower back pain Cervical neck pain Right eye injury with glass" Pt had record of receiving 2 covid vaccines from outside source. No info provided except dates given on 3/4/21, 3/25/21. Not able to assess if this death is related to covid vaccines given lack of information & no longer an active patient.
3 witnessed  seizure activity, each 30-45 seconds in duration. Pt responding immediately after, states "I had a spicy taste in my mouth and i usually put my head between my knees when this happen."  Also reports having an anxiety attack when he had his Covid vaccine.  pt reports not taking his anxiety medication since april. VS at 1125 BP 132/78 upper left arm, 02Sat 95%RA, HR77, RR 32  VS at1128 102/71 upper left arm, 02 sat 98%RA,  HR82, RR24, EMS arrival at 1132, they established an 18 gage int to LAC with 500 CC NS infusing
Patient claims that after one week, he developed a rash that required the purchase of $170+ in medication to make him cough the vaccine out of his body.  The patient did not contact a physician.
Patient received 2 vaccines Fluzone in right arm, pneumonia in left arm. She reported flu like symptoms fever, sore neck, throbbing at injection site and hardening around injection site with bruising. This subsided over a couple weeks.
1/6/22 COVID test positive; ordered by Medical Center; no medical records on this patient; pt per Death Certificate died at Hospice on 1/11/22
Dfficulty in swallowing; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Dfficulty in swallowing) and NAUSEA (Nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 031L20A) for COVID-19 vaccination.     The patient's past medical history included Gastroparesis (Gastroparesis but she claims that she is on remission.).   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced DYSPHAGIA (Dfficulty in swallowing) and NAUSEA (Nausea). At the time of the report, DYSPHAGIA (Dfficulty in swallowing) and NAUSEA (Nausea) had resolved.            Concomitant medications were not provided.Treatment information was not provided.The patient stated that she had to drink a lot of water to facilitate swallowing.Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: The outcome of all events was updated as recovered/resolved.
Body aches, headache, fatigue, and very very sore and tender under left armpit. Suspect it is swollen lymph nodes
INTENSE UNCONTROLABE HEADACHE PAIN PROGRESSING TO BACK & HIP. GALL BLADDER REMOVAL AND A SPINAL EPIDURAL FOR PAIN CONTROL.
Patient was given a Kinrix vaccine instead of the DTaP and Polio that would normally be given at her age.
Extreme pain in lower abdomen/ovaries left side, pelvic pain, excessive urination, change in bowel movement, inability to walk or sit normally without experiencing pain.
Patient called pharmacy on 10/13/2019 to report extreme pain in her right leg that she associated with receiving the Fluad vaccine. She stated her leg was numb, painful and she could hardly get out of bed.
Patient was injected with an empty syringe.  Clinic called patient back to receive vaccine.
Pt developed fever (102.7 deg F), local tenderness, diffuse myalgias. No other symptoms.
Sudden onset of "hot rush" immediately after flu-shot injection to left deltoid, followed by feeling of diaphoretic with palpitation, heart rate increase 130 sinus tachycardia, no ectopy.
initially with headache, diarrhea, stomach ache, nausea, loss of appetite then resolved 2 days later and left feeling tired and nauseated for several days. 5 days later developed tingling in legs and heaviness with change to gait. headache resolved. still with decreased energy  level.
I was unable to perform daily activities. I couldn't sleep and it was hard to move and walk as well.  I also ran a fever of 100.08.
LACK OF MOBILITY/COUD NOT MOVE AS WELL AS BEFORE; TINGLING AFTER FIRST COVID INJECTION; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (LACK OF MOBILITY/COUD NOT MOVE AS WELL AS BEFORE) and PARAESTHESIA (TINGLING AFTER FIRST COVID INJECTION) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PARAESTHESIA (TINGLING AFTER FIRST COVID INJECTION). On an unknown date, the patient experienced MOBILITY DECREASED (LACK OF MOBILITY/COUD NOT MOVE AS WELL AS BEFORE). In 2021, PARAESTHESIA (TINGLING AFTER FIRST COVID INJECTION) had resolved. At the time of the report, MOBILITY DECREASED (LACK OF MOBILITY/COUD NOT MOVE AS WELL AS BEFORE) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported.
Covid-arm; Itching; Rash; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid-arm), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE RASH (Rash) and VACCINATION SITE ERYTHEMA (Redness) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) and VITAMINS NOS for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Covid-arm), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE RASH (Rash) and VACCINATION SITE ERYTHEMA (Redness). At the time of the report, VACCINATION SITE REACTION (Covid-arm), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE RASH (Rash) and VACCINATION SITE ERYTHEMA (Redness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received their first dose of Moderna vaccine on 15-Mar-2021 and after 2 or 3 days from the shot, the patient experienced Covid-arm, redness, rash and itching on their vaccination arm. The Doctor prescribed steroids cream which the patient had been taking for 1 week twice per day.  Reportedly, the reaction was still ongoing but not itching like it was. The patient still had little red and rash.  The patient spoke with their doctor but didn't saw the doctor.  The patient was under decongestion, Tylenol, and Vitamins. Concomitant medication used by the patient also included decongestion.  Treatment medication prescribed to the patient included steroids cream.
Hello, since being vaccinated, I have had tingling in my left hand and left foot. My blood pressure has spiked significantly. I have a brain fog that has not ceased and I am on day 4 after being vaccinated. I also have a mild chest pain.
I have irregular breakthrough bleeding. Irregular period/spotting. Early period. Like the link between hormonal oral contraceptives and depression, it appears that again side affects relating to women?s reproduction are not worth considering.
Patient had dizziness followed by syncope, as well as vomiting. Exact time unconscious was unknown, <5 minutes. Vitals returned to WNL within 15-20 minutes. Patient assessed by FD and declined transport, referred to get checked further by GP.
I had two Pfizer shots and took the Moderna Booster shot.  On 12/1, severe pain started in my sternum area.  It could be costocondritis.  Pain is still present.
I had a breakthrough case of Covid-19 felt like I had a cold runny nose and cough.
Developed significant alopecia which progressed from facial hair to scalp hair to hair on chest, arm and leg.  Much of the remaining hair turned white and changed texture.  Much has grown back currently but beard remains white.  Historical pictures provided by patient.  Symptom: Alopecia (hair loss) comment: 704.00
p/vax rt upper arm became reddened, blotchy w/in 15-20" of vax;
Unspecified intracranial injury with loss of consciousness of unspecified duration, initial encounter Fall while sleeping two days after receiving vaccine injured finger and head
pt states on 11/20/21 she started having strong irregular heart palpitations from 7:30 pm to 4:30 am the next morning.  She was having an erratic fast heart rate that was abnormal.  (She did not have chest pains or any type other heart attack symptoms).  On 11/22/21 at 3:30 pm she started having these symptoms again so at 6 pm she went to a local ER.  She was hooked up to heart monitors. She had EKG and IV.   She was diagnosed AFIB.  She was admitted and treated for 2 days and was discharged on 11/24/21.  She had FU appt on 12/7/21.  She wore a heart monitor from April 12th through April 26th.  She is still being treated by her Cardiologist and currently on Eliquis and Flecainide medication.
Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves 17 year old male patient who was vaccinated with a dose of 0.25 ml of FLUZONE QUADRIVALENT (batch number: UT6259LA, expiration date, was not reported) via intramuscular route in right deltoid or arm, on 01-Oct-2018. The patient's medical history was not reported. In Concomitant therapy the patient received a dose of MENACTRA on 01-Oct-2018. It was an actual medication error due to underdose (gave 0.25 ml instead of 0.5 ml to adult). Patient had no adverse event. 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 Directive 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. List of documents held by sender: none.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX dose 1 (dose, lot # and expiry date unknown). On 19-MAR-2009, the patient was vaccinated with second dose of VARIVAX from lot # 661445/0525X with expiry date of 27-MAR-2010 (dose unknown) which was improperly stored. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review of records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient describes severe arm pain lasting 1 month, trouble moving arm to the back. Sounds like shoulder impingement syndrome.
tendonitis, gout pain alike; tendonitis, gout pain alike; Could not sleep; pain from upper left arm to the wrist; pain in muscle at night and it woke the patient; left arm muscle pain for weeks on and off; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (pain in muscle at night and it woke the patient), TENDONITIS (tendonitis, gout pain alike), GOUT (tendonitis, gout pain alike), INSOMNIA (Could not sleep) and ARTHRALGIA (pain from upper left arm to the wrist) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036D21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL DIHYDRATE (LISINOPRIL [LISINOPRIL DIHYDRATE]), AMLODIPINE MALEATE (AMLODIPINE [AMLODIPINE MALEATE]) and HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE SAR) for Blood pressure, SIMVASTATIN (SIMVASTATIN +PHARMA) for Cholesterol, METFORMIN HYDROCHLORIDE (METFORMIN [METFORMIN HYDROCHLORIDE]) and GLIPIZIDE (GLIPIZIDE XL) for Diabetes, TESTOSTERONE (TESTOSTERON [TESTOSTERONE]) for Testosterone low, SILDENAFIL CITRATE (VIAGRA) for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (left arm muscle pain for weeks on and off). On 26-May-2021, the patient experienced INSOMNIA (pain in muscle at night and it woke the patient) and ARTHRALGIA (pain from upper left arm to the wrist). On an unknown date, the patient experienced TENDONITIS (tendonitis, gout pain alike), GOUT (tendonitis, gout pain alike) and INSOMNIA (Could not sleep). The patient was treated with ETODOLAC for Symptomatic treatment, at a dose of 300 mg. At the time of the report, INSOMNIA (pain in muscle at night and it woke the patient), TENDONITIS (tendonitis, gout pain alike), GOUT (tendonitis, gout pain alike), INSOMNIA (Could not sleep), ARTHRALGIA (pain from upper left arm to the wrist) and MYALGIA (left arm muscle pain for weeks on and off) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication Viagra (indication as reported for sex)
Case experienced no Covid-19 symptoms. Tested positive for Covid-19 on 10/08/2021. She was admitted to Hospital on 10/6/21, testing negative for Covid-19 on 10/6/21. Patient was transferred on 10/8/21 to a mental health facility, and was discharged on 10/15/21.
I woke up the morning after my shot and I had some pain around my left clavicle when putting pressure on it (turning in bed, etc. ) and I felt around and there was a small lump. Seems like a swollen lymph node. Today (2 days later), the area is more tender and a little larger upon palpation.
BLOOD CLOT IN HEART LAD (LEFT ANTERIOR DESCENDING ARTERY); HEART ATTACK; CARDIAC ARREST; This spontaneous report received from a consumer concerned a 58 year old, male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user (rarely), and non smoker, and other pre-existing medical conditions included: The patient had no known allergies and no drug abuse or illicit drug usage. The patient was on no medications prior to the event. The patient was previously received covid-19 vaccine ad26.cov2.s (Dose number series 1) (suspension for injection, route of admin not reported, batch number: 1855190 expiry: UNKNOWN) dose was not reported, 1 total administered on 01-OCT-2021 in left arm for covid-19 prophylaxis. It was unknown if patient experienced any adverse event after covid-19 vaccine (Dose number series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number series 2) (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 27-APR-2022 in left arm for covid-19 prophylaxis. Age at time of vaccination 56 years old. No concomitant medications were reported.  On 20-OCT-2023, the patient experienced blood clot in heart LAD (left anterior descending artery), the clot was presumably in heart for long time and passed while patient was running on treadmill. The patient had a heart attack that caused cardiac arrest (Dose number series 2). The CPR (Cardiopulmonary resuscitation) was performed on patient. The patient was on no medication prior to event. The patient had to put stent in and currently wearing external defibrillator. The patient was on acetylsalicylic acid (aspirin), blood thinner, statins. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot in heart lad (left anterior descending artery), heart attack and cardiac arrest was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20231138879-blood clot in heart LAD (left anterior descending artery), heart attack,  cardiac arrest. The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration.
negative reaction from covid shot; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (negative reaction from covid shot) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In October 2022, the patient experienced IMMUNISATION REACTION (negative reaction from covid shot). At the time of the report, IMMUNISATION REACTION (negative reaction from covid shot) outcome was unknown.            No concomitant medication was reported. It was unknown if patient was enrolled in COVID-19-Vaccine Trial. No treatment medication was reported.   This case was linked to MOD-2022-679861 (Patient Link).
Severe right arm pain that extends into shoulder and back, down into ribs, right side abdominal pain, fever, fatigue, body aches.
a circle the size of 50cent piece is red and hard; A spontaneous report was received from a consumer concerning a female patient of 70 years of age,who was administered with Moderna's covid-19 vaccine and experienced a circle the size of 50cent piece as red and hard.  Patient's medical history was not provided .No relevant concomitant medications were mentioned.  On 28-JAN-2021, patient received the first of two planned doses of mRNA-1273 vaccine(Lot number:012M20A) for prophylaxis of covid-19 infection.  On 29-JAN-2021,patient experienced a circle the size of 50cent piece  as red and hard. No treatment information was provided.  Action taken with second dose of mRNA-1273 in response to the event was not reported.  Outcome for the event was considered not resolved.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.  The reported events are consistent with the known safety profile of mRNA-1273.
PT HAD 1ST COVID-19 VACCINE DOSE AS THE PFIZER COVID-19 VACCINE ON 2/24/21, AND CAME IN 3/16/21 TO GET 2ND COVID VACCINE. ON 3/16/21  THIS PATIENT WAS INADVERTENTLY GIVEN THE WRONG VACCINE AS A MODERNA COVID-19 VACCINE (INSTEAD OF A 2ND PFIZER VACCINE).